JOB SUMMARY VP of Quality & Regulatory:
Leads and manages the Quality & Regulatory organization and all Quality related programs and activities to support site operations. Functions and activities include Quality Control, Quality Assurance, Validation, GMP Training, Compliance and Regulatory. Ensures business, quality and compliance goals are met in full compliance with all Gallus and relevant government issued quality and regulatory policies/guidelines.
Reserve your spot for Bounce Back’s Nitty Gritty Workshop or forward to friend so they can attend.
Nitty Gritty Workshop
Thursday, November 14, 2013 Whether you are just starting your job search or looking to inject new energy into your efforts the Nitty Gritty workshop is for you. This all day workshop will help you prepare or revise your marketing plan, learn to network and prepare to interview like never before.
Join the Bounce Back team that will help you….. Identify your skills that you will use to market yourself Learn to write accomplishment stories to use during interviews and networking meetings Learn to write your Personal Marketing Message that will make you memorable Construct your resume that will pass the 30 second thumb tests Learn to use LinkedIn – the #1 on line job search tool Learn how to network to uncover the hidden job market Learn how to interview to stand out from the other candidates Next steps for support after the workshop This workshop is free, but reservations are required. To reserve your seat please respond to: email@example.com
- Date: Thursday, November 14 Time: 8:00 am till 5:00 pm Location: Webster Groves Christian Church, 1320 West Lockwood, 63122
Invite a friend to join you at this weeks meeting.
LinkedIn! LinkedIn can be one of the most valuable tools in your search. Come learn how to be more effective with LinkedIn.
- Date: November 01 Time: 8:30 – 11:30 am Webster Groves Christian Church 1320 West Lockwood Webster Groves, MO 63122
Best Practices! Come share your and learn others’ best practices of job search. One great idea could be the difference in your search.
- Date: November 08 Time: 8:30 – 11:30 am Webster Groves Christian Church 1320 West Lockwood Webster Groves, MO 63122
Hot Job Interview Tip: ‘Cut To The Chase’
By Jimmy Sweeney, President of CareerJimmy and Author of the new, Job Interview "Secret"
Wouldn’t it be simpler and easier if you could count on a hiring manager to get right down to business and ask the one question that is probably uppermost on his or her mind? "What can you do for our company that no one else can do as well?"
What a powerful query that is. However, most interviewers start with questions that fall into three areas: employment experience, workplace communication, and your personality style. In other words, he or she wants to get a feel for who you are as you relate to these categories. Your answers will help determine if you are someone to interview again and/or hire. These questions appear to be a less confrontational way of asking the one thing they really want to know.
So what should you do? Be prepared for any and all potential questions. Then when they come up you’ll have your responses ready. Also, depending on the interviewer you may be asked questions that require a direct answer such as, "How long were you at your previous employment?" or "What were your daily tasks in your former job?"
OR an individual with a more casual style may put her query this way. "Tell me about a day on the job at your previous employment," or "What did like best about your job and the duties you had?" See the difference? You may provide the same basic answers to both but you’ll phrase them according to the way the employer presents the questions.
However, regardless of the approach the interviewer takes, keep in mind that what he or she is really asking is the question in the first paragraph above. "What can you do for our company that no one else can do as well?" By checking you out in various ways, he or she is looking for the answer to that question because it is the one that ‘cuts to the chase’. It gets to the bottom line. It brings the interview into focus. It may determine whether or not you get the job.
Whatever the question, approach it in a relaxed and easy manner. Think ahead about the categories involved–your experience, your communication, and your personality because they will be the ones that will grab the hiring manager’s attention and convince him or her that you’re the one who can offer the company exactly what it needs–and you can do so better than anyone else.
BE ON TASK
In a way it’s up to you to ‘cut to the chase’ too. Don’t wander around, spouting words that take up time and confuse the interviewer. Avoid getting side-tracked. Stick to the point of why you want this job and why you believe that you can be an asset to the company and its mission.
Interviewers are busy people, seeing one person after another for hours at a time. In order to stand out in this line of individuals, you’ll need to stay focused and clear-minded. Keep thinking ‘cut to the chase’, to help you offer only those details that will advance the interview to a place where you can tell the employer is favorably impressed with you.
Most company managers are looking for several key traits: passion, attention to detail, problem solving, leadership, commitment, communication skills, and intellectual curiosity.
Before you walk into the interview room pull together some specific examples from your work life that illustrates a few of these characteristics. At just the right time bring them up and share them as a story, including details, dialogue, conflict, and resolution. In other words, what happened, who was involved, and how did you resolve the problem so the outcome was successful? Whether or not you are asked for examples directly doesn’t matter. Just have them ready to insert into your answers as they seem suitable.
If you enter an interview with a ‘cut to the chase’ attitude for yourself then you’ll likely find the interviewer will do the same–and offer you the job.
Jimmy Sweeney is the president of CareerJimmy and author of the brand new "Secret Career Document" job landing system. Jimmy is also the author of several career related books and writes a monthly article titled, "Tough Times Job Tips."
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Title-Systems QA Analyst 5
Client – Wells Fargo
· 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.
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.
· 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:
· 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.
· 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
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
Kevin M. Martin
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
Human Resource Manager
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.
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.
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.
-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
-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
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
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.
Quality Testing Services, Inc.
Office phone: (314) 770-0607