Apex Systems Senior Quality Assurance Specialist in St. Louis, Missouri
Senior Quality Assurance Specialist in St. Louis, MO at APEX Systems
Date Posted: 1/5/2019
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St. Louis, MO
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Job Description Job #: 915224
Senior QA Associate
Direct Hire opportunity in greater St. Louis, MO area for a large Pharmaceutical company, offering relocation and full benefits.
The Quality Associate 3 is an experienced QA professional that provides leadership and experience with introduction of new client molecular entities, performs client quality project management, assists the client in Quality needs and understanding of Quality guidelines and Regulations, and ensures commitments and adherence to Quality Agreements.
This individual is a recognized subject matter expert in one or more of the following Quality Assurance areas: cGMP compliance, deviation management, or pharmaceuticals manufacturing.
This individual is responsible for overseeing quality aspects of one or more clinical and / or commercial products with respect to: master batch record approval, disposition of product, review of process validation protocol, change control approval and ensuring alignment of the programs with respect to phase appropriate requirements and strategies.
Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects.
Offer guidance and oversight on all aspects of quality to drive clinical and commercial programs toward successful outcomes.
Act as Liaison between the Client and sub-groups of Quality Assurance during technology transfer of new products
Ensure development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines.
Oversight to include work from early phase GMP manufacturing through Commercial.
Review and aid in the establishment and maintenance of Client Quality Agreements for assigned programs.
Review and approve GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures, Process Validation Protocols, Deviations and Change Controls.
Contribute to continual process improvement by participating in meetings, seminars, and site projects.
Bachelor’s degree in Biology, Biochemistry, Chemistry, or other science related field.
At least 5 years of experience in a regulated manufacturing environment with direct Quality Assurance experience
Must be independent, results oriented and have a depth of experience in regulatory requirements for manufacturing of API including, facility clean room requirements, batch record and technical transfer protocol review for clinical and commercial GMP manufacturing
At least 10 years of experience in a regulated manufacturing environment may be considered
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178