Job description

Job Responsibilities:

• Review documentation for Quality approval
• Review of Batch Records and other documentation in support of final product disposition
• Perform batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained
• Assure that finished product is not released until the appropriate release testing and batch record review has been performed
• Review finished product and batch documentation and check against the registered specifications
• Assure cGMP's and company procedures are followed and, if needed, procedures/policies are revised
• You will partner with manufacturing personnel and other departments as needed, to resolve issues on the manufacturing floor
• Drafting and processing quality agreements with CMOs and contract testing labs
• Participate in internal and external meetings, Business Review Meetings and site audits to ensure GMP & GLP compliance

Qualifications:

• Bachelor's degree in Biology, Chemistry, Biochemstry or other related discipline.
• 3+ years of QA experience within biopharma/biotech
• Experience in FDA, GMP, and GLP regulations
• Experience with Continuous improvement, Six Sigma, and/or Lean principles is desired

Job Type: Full-time

Pay: $95,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Fall River, MA: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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