Sr. Associate, QA- Quality & Compliance in Cambridge, MA at Apex Life Sciences

Date Posted: 10/30/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Our client, a top Cambridge based biopharmaceutical company, is looking for a Sr. Associate, QA- Quality & Compliance. This person will have the opportunity to report directly to the Senior Director, Quality Assurance and will be responsible for routine coordination of GXP compliant systems for quality compliance activities and initiatives including Deviation Management, Change Control, and Vendor Qualification.

Primary Job Responsibilities:

  • Provide quality guidance on deviations, CAPAs and change controls, issue log numbers, monitor due dates and archive. Prepare related metrics for Quality Management Reviews.
  • Track quality metrics including audit observations, temperature excursions (shipping and on-site), lot disposition and risk assessments.
  • Assist in generation of Quality (Management Review) Council metrics
  • Assist with Supplier Management review and approval (GXP) and maintain the Master Vendor Supplier List
  • Track Quality Agreements
  • Archival of CAPA, Deviations and Change Controls Documents and other quality records
  • Track and maintain Quality Risk management reports

Primary Job Requirements:

  • Bachelor’s degree in the life sciences
  • 5 to 8 years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role
  • Demonstrated people skills.  Significant experience and successful track record of line and cross-functional team management or project management.
  • Ability to work collaboratively within project teams to attain team goals.
  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking, and problem-solving with a keen attention to detail.
  • Proficient in Excel and organizing paper-based Quality Management Systems

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.



PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.


Code: RegQA

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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