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Sr Associate Compliance

Billerica, Massachusetts · Biotech/Pharmaceutical
ProStaff Workforce Solutions is seeking a Sr Associate, Compliance for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

Full-time Onsite
Direct Hire

Job Description:
The Sr. Associate Compliance (Investigations, CCR, PQCs) provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
 
  • Collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations.
  • Work directly on technical investigations relating to product quality complaints.
  • Provide verbal and written responses/resolutions to customers regarding Product Quality Complaints or product inquiries.
  • Conducts Investigations of Site Incidents/Deviations and Product Quality Complaints in TrackWise system and provides final review.
  • Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identified and completed.
  • Reviews and approves Change controls, CAPA and Global CAPA and monitors the effectiveness of CAPA.
  • Ensure adequate tools used during the investigations.
  • Participate in all manufacturing/Quality control related to the investigation.
  • Generate Summaries for the investigations; Trending of Site Incidents; Product Quality Complaints; Out of Specifications; Out of Trends on monthly; Quarterly and annually basis.
  • Ensure effectiveness check of Corrective and Preventive actions.
  • Ensure adequate risk assessments are performed using tools like Failure Mode Effect Analysis.
  • Manage investigations related to complaints, planned, unplanned deviations, FAR, Quality alerts and batch failures. Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
  • Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
  • Identifies compliance issues and supports the implementation changes for constant improvements.
  • Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice. Create new SOP’s and revise the existing SOP’s as applicable.
  • Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications.
  • Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
  • Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques.
  • Perform analysis of Annual Product Review (APR) statistics reported for each product; investigate any OOT testing results identified in the product APR; and provide written summary for inclusion in the APR.
  • Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable.
  • Drive projects to improve the QMS for compliance, efficiency, or corporate needs.
  • Author/revise standard operating procedures (SOPs) and test methods, as required.
  • Act as the Site IPC (Investigation Program Champion).
  • QRB (Quality Review Board)/IRB (Investigation Review Board) Coordinator.
  • TrackWise Site coordinator: Ensuring all users of Trackwise are trained in the roles.
  • GQS/GSOP implementation coordinator: Ensuring the site is in compliance with Sun’s Global processes
  • Other duties as assigned.

Qualifications:
  • Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
  • Working knowledge of cGMPs, GLPs
  • Strong knowledge of instrumental and wet analytical chemistry
  • Strong knowledge of microbiology testing
  • Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
  • Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
  • Demonstrated ability and knowledge of QMS and driving investigations to completion
  • Expertise level of understanding of GMPs
  • Expertise in software applications such as: Word, Excel, Office, Windows, PowerPoint, Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System), etc.
  • Knowledge of project management principles, practices, techniques and tools
  • Excellent interpersonal and communication skills, both written and verbal
  • Strong organizational and time management skills; must have ability to prioritize and manage multiple assignments simultaneously while working independently or with others as needed
  • A self-starter with a hands-on approach and a can-do attitude.
  • Strong working knowledge of MS Office software


Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.


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