GMP Operational Quality Sr Specialist (Batch Record Review)
Job Description
Title: GMP Operational Quality Sr. Specialist (Batch Record Review)
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Location: Boston, MA – Fan Pier (Onsite)
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Employment Type: Contract
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Status: Accepting Candidates
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About the Role
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We are seeking a GMP Operational Quality Sr Specialist to provide QA support for manufacturing operations, analytical laboratory operations, and materials management.
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This position is primarily focused on executed batch record review and product disposition and is largely office-based. The role requires a strong QA background with hands-on batch record review experience and GMP manufacturing environment experience.
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Key Responsibilities
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Batch Record Review & Product Disposition
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- Review executed batch records and provide approval for quality tasks
- Perform final review of executed batch and critical systems documentation
- Determine acceptability using standard operating procedures
- Ensure all required documentation is present and acceptable prior to product/system release
- Support day-to-day batch release activities
- Perform activities associated with product disposition, including batch document review and source data review
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GMP Quality Support
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- Review batch data, including batch records, deviations, in-process data, EM data, QC release testing, and quality systems documentation
- Support manufacturing activities for cGMP compliance
- Provide guidance on manufacturing quality issues
- Support shop floor checks and audit trail review
- Gown into cleanrooms and controlled environments
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Investigations & CAPA
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- Support root-cause analysis and product impact assessments for deviations, OOS, and OOT investigations
- Ensure appropriate CAPA actions are identified
- Collaborate with business partners to resolve quality issues and ensure compliant solutions
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Quality Systems & Compliance
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- Assist with quality audits and external inspections
- Maintain quality documentation and files
- Support monthly/quarterly Quality System metrics and reporting
- Escalate critical and major findings to Quality management
- Monitor key performance indicators
- Author SOPs supporting commercial quality functions
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Continuous Improvement & Collaboration
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- Represent Quality on cross-functional working teams
- Support continuous improvement projects
- Train employees and provide education on processes and procedures
- Identify and support continuous improvement opportunities
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Qualifications
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- Bachelor’s degree in a scientific or allied health field, or equivalent combination of education and experience
- Strong QA background
- Hands-on batch record review experience
- GMP pharmaceutical manufacturing environment experience
- Experience providing QA support and oversight of GMP manufacturing operations
- Good understanding of cGMPs in a pharmaceutical setting
- Experience with electronic document management systems such as:
- QDoccs
- Trackwise
- Veeva
- Strong communication and collaboration skills
- Ability to evaluate quality matters and solve problems using technical experience and sound judgment
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Preferred Qualifications
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- Experience leading event investigations
- Strong Root Cause Analysis (RCA) experience
- Strong CAPA experience
- Experience with product disposition and batch release
- Experience supporting quality audits and regulatory inspections
- Experience with quality metrics and reporting
- Experience working cross-functionally in a GMP environment
- Experience authoring SOPs
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Compensation
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- $65/hr W2
- Boston, MA – Fan Pier
- 100% Onsite
- Monday–Friday, 1st Shift
- 12+ Month Contract
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