Quality Assurance

Job Description

Job Summary: 

• Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.
• Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented.
• Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
• You will be a member of company dedicated and highly effective quality assurance team.
• You will be responsible for providing Quality Assurance support to GMP clinical manufacturing.
• You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.
• In addition, this position will perform a range of duties associated with records management to ensure compliance with regulatory requirements and company standards.

Responsibilities:

• Review and approve various Good Manufacturing Practices (also cGMP) records (primarily batch records, formulation records).
• Ensure that all documents for batch release are reviewed for completeness and accuracy.
• Support the site relative to a constant state of inspection readiness.
• Recognize when an issue is beyond your sphere of influence and escalate immediately.
• May participate in the release of raw materials, as needed.

Basic Qualifications:

• Bachelor’s Degree.
• Experience in pharmaceutical industry.

Physical/Mental Requirements:

• Mental agility to handle a large quantity and broad Product of different types of quality assurance work.
• Ability to work independently, problem solve and make recommendations for solutions.
• Role is primarily office-sitting.
• Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting.

Interviews:

• Teams Meeting.