Quality Assurance Lead
BCforward - Ayer, Massachusetts, us, 01432
Work at BCforward
Overview
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Overview
$60.00/hr - $65.00/hr Direct message the job poster from BCforward Now Hiring: QA Lead – Technical Operations | Onsite in Devens, MA Status:
Accepting Candidates Pay Rate:
$64–$65/hr (W2) Contract:
Long-term Job Summary: A leading pharmaceutical company is seeking a
QA Lead – Technical Operations
to support quality assurance activities at its Devens, MA site. This role focuses on the review and approval of quality documentation, deviations, CAPAs, validation protocols, and change controls. Candidates should have a strong background in GMP compliance and technical writing within the biotech/pharmaceutical industry. Education & Experience Requirements: Bachelor’s degree in Biological Sciences, Engineering, Biochemistry, or related field (or equivalent experience) 8+ years in GMP/GCP/GXP-regulated environments with a focus on product quality Experience with QC equipment qualification and project management Strong understanding of US & EU cGMP, GAMP 5, and Data Integrity principles Background in biotech manufacturing, bulk drug substance or finished product is highly desirable Familiarity with systems such as SAP, LIMS, TrackWise, Veeva Vault Active membership in ASQ or ISPE preferred Strong technical writing & oral communication Knowledge of QA/QC principles and practices Detail-oriented with excellent problem-solving ability Comfortable working in FDA-regulated environments Ability to work independently and manage multiple priorities Provide QA support through review and approval of investigations, CAPAs, SOPs, and validation/automation documents Review and approve change controls and ensure compliance with regulatory and internal standards Coach cross-functional teams on investigations, risk assessments, and validation processes Analyze complex data and make sound decisions independently Support data integrity compliance and continuous improvement initiatives Onsite
at Devens, MA location (38 Jackson Road, Harvard, MA) This is a fantastic opportunity to join a globally respected pharmaceutical organization and contribute to high-impact quality and compliance initiatives. Submit your resume today to be considered! Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance and Engineering Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at BCforward by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Pension plan Child care support Paid paternity leave Tuition assistance Get notified about new Quality Assurance Specialist jobs in
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