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Senior Associate, QA Compliance

4 months ago

Billerica, United States Wimmer Solutions Full time

SENIOR ASSOCIATE, QA COMPLIANCE - APQR (ANNUAL PRODUCT QUALITY REVIEW)

Billerica, MA (Onsite)


22911


At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their strategic initiatives. We have fun; we love our work. We are positive, kind, and hungry to learn. We give big; we aim to make a real impact on the causes that affect the communities we serve and build strong relationships with the dedicated volunteers and nonprofit organizations working to address them.


We are all about people and community. Since 2002, we have offered technology staffing and managed services for the greater Seattle area and throughout the United States. We focus on getting to know our clients and candidates to create lasting partnerships and ensure success.


Our client is looking for a Senior Associate, QA Compliance (APQR) who will be providing 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.


WHAT YOU GET TO DO

  • Support and 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.
  • Author/revise standard operating procedures (SOPs) and test methods, as required.
  • Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
  • Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
  • Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
  • 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.
  • Manage electronic Quality Management System (TrackWise).
  • Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems.


WHAT YOU BRING

  • Minimum 6 - 8 years related experience in a pharmaceutical manufacturing environment.
  • Working knowledge of cGMPs, GLPs.
  • Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data.
  • Strong knowledge of instrumental and wet analytical chemistry.
  • Strong knowledge of microbiology testing.
  • Strong working knowledge of MS Office software.
  • Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc.
  • Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.


Must be able to work for a US based company without requiring visa sponsorship.


COMPENSATION AND BENEFITS

  • Salary range is between $100,000 to $120,000 based on experience and qualifications, as well as geographical market and business considerations.
  • +10% bonus
  • 3 weeks paid vacation
  • 401(k) match