Systems QA Analyst 5 – Duration-4months Location – St Louis,MO

Title-Systems QA Analyst 5

Duration-4months

Location-St Louis,MO

Client – Wells Fargo

Job Description:

· Responsible for handling the most complex quality assurance and test environment problems and issues.

· Acts as a lead in the creation, preparation, and conduct of quality assurance reviews and the development and execution of test plans and test scripts. Works with client to establish and maintain a consistent test methodology and to resolve questions during the testing process.

· May serve as a coordinator for all testing activities on a project. Analyzes, tests, and certifies application-specific software and performs ambiguity reviews of business requirements and functional specification documents.

· Uses advanced knowledge of applications to provide technical assistance in identifying, evaluating, and resolving highly complex test problems.

· Researches new products and industry methodologies and facilitates the development of new concepts, techniques, and standards.

· Plans and directs quality assurance schedules and assignments, and monitors project status in comparison to cost/time projections. Logs, tracks, and verifies resolution of software and specification defects.

· Documents all phases of QA process. Directs and serves as a mentor to less experienced staff.: 7+ years IT quality assurance and systems/application testing experience.

 

Contact:
Rumki Deb
Technical Recruiter

Phone: 4156965353

VOIP: 2353

Fax: 973-292-2838

Senior Process Engineer: temp-to-perm position

 

Senior Process Engineer

Provides technical discipline and leadership required to maintain, plan and implement robust and capable processes. Identifies and implements improvements and new technologies to processes to increase productivity, improve quality and reduce costs. Is the leader of equipment troubleshooting efforts; coordinating other support groups to return equipment to service. Is the leader of product/process failure investigations; implementing corrective actions and preparing sound scientific reports. Authors and provides technical support for developing processes and equipment documents including URS, DOE and validation documents. Provides change control authority to ensure the validated status of equipment is maintained. Reviews, monitors and trends daily operating data as needed, issues reports and recommendations based on operating data. Technical requirements include a thorough and demonstrable knowledge of cGMP’s and applicable Industry standards.

 

ESSENTIAL FUNCTIONS:

· Composing User Requirements Specifications (URS) for equipment and upgrades.

· Maintain control of area process changes and serve as the primary departmental owner of equipment management of change activities.

· Providing adequate and documented monitoring of the process through trending, run reports, and tracking Operational Equipment Efficiency (OEE). Use OEE to identify process improvements.

· Leading process troubleshooting efforts.

· Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.

· Identifying capital needs for the process.

· Support departmental change initiatives for continual improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications. Primary departmental driver for cost reduction initiatives.

· Facilitate technical transfers with R&D.

· SME for the process.

· Provides annual capacity analysis.

· Provides technical expertise to project management teams during project lifecycles.

· Executes projects, including:

· Purchases of equipment (lab furniture, laboratory equipment, process research equipment, etc.)

· Composing associated CER and processing financial information.

· Capital funding for outside services as it relates to manufacturing (risk assessments, validation services, process engineering assistance).

 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

MINIMUM REQUIREMENTS:

· Education required/ preferred: Four-year degree in Mechanical, Electrical or Chemical Engineering. (Other engineering disciplines may be considered based on experience.)

· Experience: Minimum Five (5) years experience working as an engineer in a FDA regulated facility.

· Minimum two years of Manufacturing Experience; preferable in the manufacture of finished pharmaceuticals.

Preferred Skills/Qualifications:

· Verifiable knowledge of and experience in application of cGMP’s, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.

· Experience in applied knowledge of aseptic behaviors and techniques associated with pharmaceutical production.

· Experience with aseptic manufacturing equipment (Depyrogenation Ovens, Isolators, Lyophilizers, Liquid Fillers, etc.)

· Proven experience in leading teams, groups or efforts relating to processes and equipment.

 

Skills/Competencies: MS Office, Proficient in MS Excel

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

WORKING CONDITIONS:

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.

This is a 3-6 month position

First shift

 

Contact:

Kevin M. Martin

(618) 580-7910

Quality Assurance Technician – Hydromat Inc.

image

 

SUMMARY: Responsible for the Quality Assurance activities of the organization within a production environment

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Candidate must be able to perform the following with proficiency:
• Open surface plate set-ups.
• CMM utilization and program generation for part inspections, process validation, and calibration services.
• Drawing interpretation.
• Calibration of measuring and test equipment.
• Basic repair and/or adjustment and servicing of measuring & test equipment.
• Receiving inspection activities based on established procedures.

Candidate should be able to perform the following with accuracy:
• Conducts the analysis for inspection, to assure the quality of assigned product or component.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
• Communicates significant issues or developments identified during quality assurance activities.
• Prepares and presents technical and program information to team members and management.
Qualified individuals will possess the following at a minimum:
• Moderate skill in blueprint reading and interpretation.
• Working knowledge of geometric dimensioning and tolerancing (GD&T)
• Knowledge of shop math and some geometry & trigonometry
• Ability to analyze data and respond accordingly.
• Working knowledge of Windows software environment, PC literate
• Self-motivated and detail oriented in a fast-paced environment
• Good communication skills (verbal and written)
• Proficient in use of all standard measuring instruments micrometers, dial indicators, gauge blocks.

Individuals with the following will have exclusive consideration:
• 2+ years of experience as a CMM operator with some programming on a Zeiss or similar machine is preferred.
• Knowledge of S.P.C. and capability studies
• Knowledge of C.A.D. software and drawings
• ISO-9001/TS16949 knowledge and experience

 

 

Kelley Dumey

Human Resource Manager

Hydromat Inc.

p: 314.432.4644
f:  314.692.5161
e: kdumey@hydromat.com

May meeting held at the Engineer’s Club

The evening starts with SEED presenting a Dance exhibition

Afterward, the “SMED Heads”, will present their award-winning improvement project. The SMED Heads are an international, cross-functional improvement team working at Mallinckrodt, the Pharmaceutical business of Coviden. The SMED Heads formed to evaluate and optimize the existing cleaning procedure for the large-scale production equipment in Mallinckrodt’s pharmaceutical salts facility. 

Read More»

Workshop: Converting your Quality Skills to the Healthcare Industry


Have you ever contemplated going into healthcare?  It is a growing industry and they need people from other industries with quality and process improvement skills.  Come attend this workshop to see what’s all involved in making the transition to the Healthcare Industry. As part of this workshop: well how examples of healthcare projects and  we will review resumes to see how you can tailor you quality skills to match the healthcare requirements. 

When: Jun. 22, 2013
Time: 8:00am – 12:00pm
Where: St. Louis Community College – Corporate College
Facilitator: Kim Rochetti, President, Strategic Operating Systems
Sign up or ask questions by calling 314-838-4659.

 

Register Now!

 

 

Facilitator Bio:


Kim Rochetti transitioned from Boeing Aerospace after 22 years and spent 2 years in healthcare, assisting them improve their processes.  She’s a Master Black Belt, CSSBB, CQE, and PMI PMP with about 30 years of process improvement experience.  She recently started her own consulting business, Strategic Operating Systems, deploying Continuous Improvement Systems at companies in various industries.

http://strategicoperatingsystems.com/wp/

LC Meeting Minutes April 9, 2013

ASQ SECTION 1304- Saint Louis

Minutes of April 9, 2013 LC Meeting

Location– Yacovellis– 407 Dunn Rd, Florissant, MO 63031

Call to order: The meeting was called to order at 6:18 pm.

Participants: Officers and LC members: Rod Toro, Gail Keefe, Denise Arthur, Katarina Gowan, Tony Indehar, Randy Thompson, Kunita Gear, Jim Ebone. Kim Rochetti, Mark LeClair,

A quorum was present.

Business:

Approval of the Minutes: The March 12, 2013 LC meeting minutes were reviewed an approved.

HQ News: N/A

Officers’ Reports:

QMP Goals: (Denise Arthur – Vice-Chair): Denise presented QMP results. Attendance at previous membership meeting was 76 (YTD836). Still need a half day workshop (to be remedied in June).

Treasurer Report – Qtrly, Monthly status (Katarina G-Treasurer):

February statement total: $ 64,831 (checking and MM balance) as of 4/9/13.

MM Balance: $57,501

Checking Balance: $7,331.47

Pending requests: $172 Quality Council of Indiana (CQA instructor)

$24.15 wal-mart supplies for Treasurer (binder, labels,)

$1858.90 Dave & Busters

2 @ $ 399 refund for cancelled CSSGB class

Previous minutes’s action items unresolved (Gail K- Secretary):

No Report

Board Reports:

Education Jesse will be resigning in July but has indicated he will assist with the transition. We will be needing a new Education Chair.

Status of classes –

CSSGB class was cancelled. We only had 2 people sign up despite the numerous solicitations.

CQE, we are currently having the class, there are only 3 people in the class.

CQA class is scheduled to begin on Thursday, (a big THANK YOU to Cynthia Duhigg, aka Cindy) who volunteered to teach the course at the last hour for us. We have 4 people signed up for the class

CQIA, it looks like this class will be cancelled due to lack of interest.

Certification No Report.

Recertifications – Kunita G.- Nothing new to report. Things OK.

Membership – No report.

Arrangements

The April membership meeting will be held at Yacavelli’s on April 16th.

The May membership meeting will be at the Engineer’s Club on May 21. Pre-Dinner: SEED Presentation and Dancing Exhibition; Key Speaker: Leah C. Lorendo, Ph.D., CCC-SLP

There will be a workshop tentatively set for June 8, Kim Rochetti will give a workshop on how to convert into the Health Care Industry.

News letter – No report.

Social Networking– No report.

Standing Committee Reports:

None

Special Orders (special topics that the chair wants to bring up): Rod indicated that he would send out an email blast that our Chapter Website is up and running. Mark L will be adding Job postings to our website so any one who has job postings should forward to Mark.

Unfinished Business:

ASQ conference: Rod gave an update on the travel arrangements.

Motion: Katarina made a motion that the room and board be paid for those leadership committee members who are attending the conference. The motion carried.

Workshops: Kim Rochetti will do a workshop on June 8th on Converting to the Healthcare Industry.

New Business:

In the next few LC meetings we will be transitioning to the new officers. The June LC meeting (June 11) will be training for the new officers.

Tableau, a software by Data Visualization, was discussed for possible use in managing membership data. It will be discussed further in September.

The May membership meeting will be held May 21 at the Engineer’s Club.

Other: N/A

Announcements: Next LC meeting will be 2nd Tues of month May 14 , location Yacovellis.

Adjournment:

Motion: A motion to adjourn was made by Jim E. The motion carried and the meeting was adjourned at 8:20 pm.

10TH ANNUAL ASQ LEAN–SIIGMA CONFERENCE AT SIIUC

The 10TH ANNUAL ASQ LEAN-SIGMA CONFERENCE AT SIUC will be held Thursday, April 25, 2013 on the 2nd floor of the S.I.U.C. campus Student Center, 1225 Lincoln Drive, Carbondale, IL. Check-in begins at 8:00 a.m., sessions start at 8:30 a.m. Continental breakfast and lunch will be provided.

 

Flyer

 

Topics / Speakers

Job Posting – SR. QUALITY SPECIALIST – ID 17844 – Missouri

ABOUT EXPRESS SCRIPTS 
Advance your career with the company that makes it easier for people to choose better health.

Express Scripts is a leading healthcare company serving tens of millions of consumers. We are looking for individuals who are passionate, creative and committed to creating systems and service solutions that promote better health outcomes. Join the company that Fortune magazine ranked as one of the “Most Admired Companies” in the pharmacy category. Then, use your intelligence, creativity, integrity and hard work to help us enhance our products and services. We offer a highly competitive base salary and a comprehensive benefits program, including medical, prescription drug, dental, vision, 401(k) with company match, life insurance, paid time off, tuition assistance and an employee stock purchase plan.

ABOUT THE DEPARTMENT
The Sales & Account Management organization is Express Scripts’ key interface with prospects and clients and is organized by market segment. This organization focuses on providing consultative support to plan sponsors through benefit design recommendations and clinical expertise and is primarily accountable for growth of Express Scripts’ gross margin and membership base.

RESPONSIBILITIES
Assist management in the development and implementation of quality and risk management initiatives.  Contributes to the build and management of TPharm quality and risk-related activities, including the facilitation of root cause analysis and making process improvement recommendations.  Efforts may include facilitating quality/process improvement projects.  Work with cross-functional stakeholders to document quality activities and risks while keeping the contract requirements in perspective.  This activity will include post audit processes that support quality improvement for the current DoD contract.  Working under general supervision, ensures quality and risk-related documents are complete, current, and stored appropriately.  Utilize the Microsoft suite of software, including Access, Excel, as well as Minitab to support the development of the TPharm quality and risk management processes.  Provide continuous support and backup for other quality and risk management activities.

ESSENTIAL FUNCTIONS:

1. Working under general supervision, work on efforts that involve the development of quality-related initiatives to support the division’s quality management system development.   Includes the development of quality management policies and procedures.

2. Coordinate with cross-functional teams that will identify specific quality controls or support the development and monitoring of process controls in support of the current DoD contract.  This may include support or management of quality/process improvement efforts.

3. Design, implement and complete statistical analysis to support quality management using Minitab and or Microsoft Excel.

4. Assist in the identification, tracking and support of risk that may impact the TPharm contract.

5. Assist with the development of user training manuals and training plans for divisional risk and quality initiatives.  May assist with training users and launching operating procedures related to quality and risk management.

6. Provide routine briefings to supervisor on the status of quality monitoring and risk-related activities.

7. Other duties as assigned, including the support of functional and organizational initiatives.

QUALIFICATIONS
-Bachelor’s degree in business administration or related area of study.  MBA or Lean Six Sigma Green Belt training preferred.
-5-7 years in a business environment
-2+ years in quality management role
-Ideal candidate should understand or have Six Sigma/ Lean skills in order to propose changes/solutions resulting in efficiency or error reduction to increase client satisfaction.
-Ideal candidate will have a related process certification such as Lean, Six Sigma Green Belt or Process Reengineering
-Working knowledge of Minitab or other statistical software
-Working knowledge of Visio and Microsoft products
-Knowledge of quality management systems
-Experience in quality control analysis
-Working knowledge of general statistics
-Working knowledge of Six Sigma quality tools
-Demonstrated advanced communication, analytical, and organizational skills
-Ability to work individually and within a team dynamic
-Detail oriented
-Strong presentation skills
-Ability to work with a very high degree of autonomy and strategic input
-Ability to work well with minimum supervision
-Ability to multitask and meet deadlines
-Good communication and customer relations skills
-Experience with the principles of continuous quality improvement, brainstorming, cause and effect analysis, root cause analysis and graphic representation of data

Apply online: www.express-scripts.com

Job Posting – Quality Engineer – Arnold MO

 

LMC Industries, Inc., a growing St. Louis based automotive, consumer products, agricultural and medical components manufacturer has an immediate opening for a Quality Engineer.

This is a manufacturing-focused position which provides engineering support in safety, new product startups, process improvements, waste reduction, problem solving, 8D reporting, auditing, and cost reductions in meeting company goals and objectives.

 

RESPONSIBILITIES AND DUTIES:

  • Participate in cross functional teams which develop new and revised products and process to meet customer requirements and project timelines.
  • Serve as quality liaison with customers regarding corrective action, product quality analysis and 8D logistics.
  • Identify and implement continuous improvement activities as it relates to product and process quality.
  • Function as quality liaison between purchasing, engineering, manufacturing, and suppliers to identify and resolve quality issues. Evaluate and develop suppliers.
  • Serve as a technical resource to manufacturing, resolving issues that may have an impact on product quality.
  • Take ownership of the quality system for assigned areas and projects. This includes: control plans, process capability studies, visual aids, forms and other associated documents.
  • Maintain production control plans consistent with the requirements set forth in the AIAG Advanced Product Quality Planning (APQP) Reference Manual.
  • Conduct capability studies and measurement system analysis; prepare test and inspection plans to support manufacturing quality criteria. Conduct audits to ensure manufacturing process conformance.
  • Maintain quality records that support APQP planning and the TS 16949 quality system. Develop and deploy forms and record retention procedures when needed.
  • Take corrective and/or preventative action when the product or process does not conform to stated requirements. Take preventative action based upon the regular review of quality assurance data to reduce variation and waste.
  • Investigate causes of non-conforming product and disposition appropriately.

 

The ideal candidate will have a Bachelor’s Degree in Engineering, ASQ certification and a minimum of five years’ experience in an inspection/quality function within a manufacturing environment.

Candidates should submit their resume, with compensation history and expectations, to the address and/or email below for consideration:

 

LMC Industries, Inc.
Attn: Human Resources
100 Manufacturers Drive
Arnold, MO 63010
glpolach@lmcindustries.com

Job Posting – Quality Assurance Manager Position – Maryland Heights

 

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Quality Testing Services, Inc. is a materials testing company that performs nondestructive testing, training and calibration services. We have been in business over 20 years and are centrally located in Maryland Heights (St. Louis), Missouri near Westport Plaza. QTS is ISO-Guide17025 accredited, NADCAP accredited and is an FAA repair station. We have a diverse client base and work with a wide range of industry requirements.

Some of the highlights of the position include:

  • Directs, oversees and coordinates all documents and activities involving our QA program including the Quality System Manual. Performs internal audits and leads customer audits and performs contract review. Review and write procedures. We also offer an excellent benefits package.
    Qualifications: One to two years working in a quality capacity for a company with an accredited Quality system. Must be ethical, practical, detail oriented, capable of analyzing specifications and codes. Must be able to communicate and work well with others and be capable making the right decision even if it is not the popular decision.

 

Scott Zimmer
President
Quality Testing Services, Inc.
Office phone: (314) 770-0607
scottzimmer@qualitytesting.net
www.qualitytesting.net

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