Sr. Associate Compliance (Product Quality)

Billerica, MA

Posted: 11/09/2023 Industry: Scientific Job Number: 23-00554

Job Description

Sr. Associate Compliance (Product Quality) Fulltime Onsite
We can Relocate
We need the emphasis to be on QA Product Quality Compliant Investigations handling (PQC). End to end to close out the investigations backlog is top priority. APQR is also good to have.

Job Duties:
The Sr. Associate Compliance 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.
  • 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
  • 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 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
  • Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
  • Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
  • Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
  • Author/revise standard operating procedures (SOPs) and test methods, as required
Other duties as assigned

Education and Experience:
  • BS in chemistry or related scientific field
  • Superior internal and external customer service/people skills
  • Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
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
Strong familiarity with

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About Billerica, MA

Discover your next career opportunity in the vibrant area surrounding Billerica, Massachusetts! This bustling region offers a perfect blend of scenic beauty, historic charm, and abundant growth opportunities. From the picturesque hikes at Great Brook Farm State Park to the buzzing arts scene at The Brush Art Gallery and Studios, Billerica and its surroundings have something for everyone. Immerse yourself in the rich culture of the area, savor the local delicacies like freshly caught seafood and signature Boston cream pie, and catch a game at the iconic Fenway Park while working in this dynamic and exciting region. Explore our job listings today and take the next step towards a fulfilling career in this captivating area.