Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Lead the maintenance, development and improvement of GMP quality systems, such as auditing (internal, supplier and customer), training, process validation, cleaning validation, equipment qualification, change control, complaint handling, and documentation control.
?á Review executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.
?á Write and/or review Operation Procedures, Master Manufacturing Formula and other QA-controlled documents for all Departments under a QMS. Coordinate the security and availability of the approved documents to all Departments.
?á Assist in the technology transfer process by providing technical input throughout the development and scale-up to commercial scale for new products governed by GMP or ISO based Quality Management Systems.
?á Review customer requests for product agreements pertaining to product specifications, testing protocols, label and documentation requirements.
?á Participate in internal audits as needed.
?á Respond to quality-related customer questions.
?á Present various GMP quality systems training topics to production, laboratory and quality personnel, if needed.
?á Assist in the resolution of customer complaints pertaining to quality and process related issues, if needed.
?á Assist with recalls and field corrections as needed.
?á Participate in governmental regulatory audits as needed.
?á Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
?á Lead Project or Process Improvement initiatives
B.S./B.A. in the Life Sciences, Chemistry, or Chemical Engineering with 3-5 years experience (i.e. GMP or API environment), B.S./B.A. in a non-science with at least 10 years applicable Quality System (i.e. GMP or API environment) experience in the specific QA job function as deemed appropriate by QA Management. M.S./M.A. in the Life Sciences, Chemistry, or Chemical Engineering with 2-4 years of applicable Quality System experience.
?á Must have a good understanding of ICH Q7 or GMP Guidelines
?á Understanding of Quality Control test methodology and the associated analytical results. Familiar with the accuracy and precision of various common analytical methods
?á Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers and regulatory authorities
?á Ability to organize and prioritize tasks effectively.
?á Capacity for independent work
?á Good time management and negotiating skills required
?á Good computer 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.
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 - 14 months ago
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