Job Description
About the position
The Quality Assurance Associate II position is a contract role within the pharmaceutical industry, focusing on ensuring compliance with regulatory and quality standards. The role involves reviewing and approving GMP documents, managing quality risks, and collaborating with project teams to maintain high-quality standards in pharmaceutical processes.
Responsibilities
Ā Review and approve GMP documents, including batch records, analytical specifications, validation protocols, and Certificates of Analysis, ensuring compliance with regulatory and quality standards.
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Ā Organize and maintain project deliverables, supporting efficient project workflows with external partners.
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Ā Proactively identify and communicate quality risks, balancing project objectives with business goals.
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Ā Participate in deviation management, risk assessments, and change control processes in alignment with SOPs and quality standards.
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Ā Represent Quality on CMC Quality sub-teams for assigned projects, promoting collaboration and alignment with project and quality objectives.
Requirements
Ā 3-6 years of experience in the pharmaceutical industry, with flexibility for candidates with slightly less experience.
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Ā Minimum of 2 years in a pharmaceutical setting, with at least 1 year in a quality-focused role.
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Ā Preferred: Master's degree (M.S. or MBA) with 2 years of pharmaceutical or GMP experience, including at least 1 year in a quality role.
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Ā Alternative: Bachelor's degree in a Science field with 4 years of experience in a pharmaceutical or GMP environment, including 2 years in a quality role.
Nice-to-haves
Ā Project management experience
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Ā Knowledge of EU and FDA regulatory standards
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Ā GMP compliance
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Ā Aseptic processing expertise
Benefits
Ā Medical insurance
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Ā Dental insurance
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Ā Vision insurance
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Ā Life insurance
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Ā Short-term disability
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Ā Additional voluntary benefits
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Ā EAP program
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Ā Commuter benefits
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Ā 401K plan
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Ā Paid Sick Leave
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Ā Holiday pay
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