PURPOSE OF THE POSITION
Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Support the maintenance, development and improvement of GMP quality systems, such as auditing (internal, supplier, and customer), training, process validation, cleaning validation, equipment qualification, environmental monitoring, water monitoring, change control, complaint handling, and documentation control.
ESSENTIAL JOB FUNCTIONS
Ensure acceptable product and process consistency by reviewing executed GMP batch documentation.
Write, review, and approve Operating Procedures, Manufacturing documents and other QA controlled document under a Quality Managed System (QMS).
Interact with internal customers and implement quality systems.
Support Sigma-Aldrich quality systems such as internal and external audits and customer complaints.
Education: Bachelors degree with 0-2 years experience in GMP manufacturing, validation, QA, QC, or other functional area applicable to the job or an Associates degree with 3-5 years applicable GMP experience in the specific QA job function as deemed appropriate by QA Management or at least 5 years experience with a degree not specified in a Life Science required.
Knowledge and skills -
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.
- General understanding of Q7 (current) Good Manufacturing Practices.
- Good computer skills, including proficiency MS Word, MS Excel, MS Access.
- Good time management skills.
- Excellent interpersonal skills for interacting with many internal departments.
- Ability to organize and prioritize tasks effectively.
- Capacity for independent work.
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 - 2 years ago
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