PURPOSE OF THE POSITION
The Quality Assurance (QA) Associate will utilize their experience in Life Science, Chemical Engineering, Pharmaceutical, Medical Device, or related areas to ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems.
ESSENTIAL JOB FUNCTIONS
Assist in Maintaining Quality Systems
1. Providing extensive review of manufacturing and quality control batch records, including verification of calculations, approval of MMFs, MPFs, generation of COA, and other release documents.
2. Completing customer questionnaires covering overall Quality Systems and product specific issues for all St. Louis GMP manufacturing facilities.
3. Assisting in support of quality systems including auditing, training, complaint and CAPA processes, as well as process improvement initiatives.
4. Maintain systems for tracking and trending of Quality System data and control of GMP labels.
5. Support the various departments in the resolution of issues identified during the review of production, packaging, and QC records.
6. Other duties as required
Contribute to support function of the quality systems.
1. Provide training to other personnel as requested on site quality systems.
2. Ensure that weekly walk through are performed to identify areas that may need improvement.
3. Prepare documentation as needed.
4. Maintain orderly and neat work area.
5. Set example by properly performing work according to procedures.
6. Perform other group responsibilities thoroughly and in a timely manner
1 Ensure quality documents reviewed accurately reflect current procedure. Initiate workflows and approve documents as required to ensure current procedures are maintained.
2 Document all tasks with appropriate detail in writing.
3 Follow quality procedures when review indicates any deviation from current procedure.
4 Utilize system of quality documents for tracking and maintaining control of all documentation.
5 Properly issue and review labels and other quality documentation to change status of materials.
6 Successfully complete required quality training.
7. Write and review drafts of quality procedures as assigned.
8. Record quality observations in databases as directed by supervisor to aid in quality improvement efforts.
Education: -BA/BS in the Life or Physical Sciences or Associate Degree with equivalent relevant experience required.
Experience: - 1-3 yrs experience in GMP Quality Control, Manufacturing, QA or other functional area applicable to the job function with a BA/BS degree OR - 3-5 years similar GMP experience with an Associates degree.
Essential and Critical Skills: - The successful candidate will have specific understanding of
Working knowledge of cGMP and ISO quality systems,
Extensive document review and attention to detail skills,
Very good computer skills including proficiency in Word, Excel, Access.
Time management of multi-tasking
Verbal and written communication skills
Independent, works well with direction
Logical approach for understanding systems and problem-solving
Cell culture experience preferred.
ADDITIONAL LOCAL NEEDS
Computer environment ' entire data and query information for usable reports.
Computer environment ' maximum use of computersThis section should be used for specific local requirements or needs.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 35 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.
Sigma-Aldrich offers a highly motivational and rewarding working environment with attractive salary, benefits, retirement, relocation and incentive packages including tuition reimbursement. Sigma-Aldrich fosters the growth of employees in a culture of respect and dignity with ample opportunity for career advancement.
Sigma-Aldrich is an Equal Opportunity Employer
Sigma-Aldrich Corporation - 13 months ago
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