Manager, QA Training, in Waltham, MA at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Our Waltham based, Clinical-phase biotech client is seeking to grow their team by adding an experienced QA Training Manager. This company is on the frontier of autoimmune and inflammatory disease research and boasts a robust pipeline. This is a great opportunity to grow with a fast-paced team!

Primary Jobs Responsibilities:

  • Collaborate with QA, Regulatory Affairs, CMC and Clinical Operations teams to create training matrices for each individual and/or job function across the organization in a paper-based system.
  • Ensure current training records are updated, as well as facilities training activities
  • Support the quality documentation on training activities.
  • Support SME and other training processes via data entry, reporting, and archival.
  • Assist in validation and implementation of LMS.
  • Assist in the writing of controlled documentation related to QMS

Primary Job Requirements:

  • B.S./B.A. in life sciences or related fields
  • Minimum of 4 years of training/education/document control experience, including working in a GxP regulated environment including knowledge and experience with biotech/pharmaceutical regulatory expectations and inspections.
  • Experience with quality training and the associated systems for maintaining training documentation
  • Experience working with Electronic Document Management Systems (eDMS) and paper-based systems
  • Experience establishing LMS preferred
  • Ability to work under changing demands and tight time-frames of an evolving biotech

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: DiscDevt

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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