Senior Compliance Training Associate (Onsite)

Billerica, MA

Posted: 10/27/2023 Industry: Scientific Job Number: 23-00510

Job Description

Senior Compliance Training Associate

Manage the site's training program covering cGMP requirements, and corporate policy, and other topics to a broad spectrum of professional individuals that serve company's manufacturing plant, research and development laboratories, and general business operations.

Reporting to the Compliance Head, and using independent judgment, apply ISO, cGMP, and FDA procedures and regulations to activities involving quality assurance and compliance for pharmaceuticals and medical devices.
  • Evaluate training needs and participate in the delivery of training materials for the company including Manufacturing, Quality, and Support groups ensuring compliance with the training policy and all training procedures
  • Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc.
  • Maintain a compliant training record keeping (data entry and hard-copy files) system
  • Assist in developing curricula of on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approved training content and working with area supervision, manages assignments within the Learning Management System (LMS)
  • Prepare training completion metrics for dissemination at Quality Review Board meetings
  • Work with area managers to determine training frequency/re-training intervals based on roles and responsibilities
  • Assist in developing training assessment tools, such as tests and competency evaluation worksheets
  • Review Quality records to ensure conformance to approved procedures and cGMP
  • Maintain an annual scheduled training calendar, ensuring on-time delivery of annual GMP training and other GxP trainings
  • Act as Single Point of Contact (SPOC) between Corporate Documentation & Training group and site, working towards harmonization of the site training and site procedures with Corporate expectations
  • Creates and manages documentation requests in electronic systems such as EDMS, Master Control, and Trackwise. In a timely manner to meet established deadlines
  • Assists in monitoring documentation due for annual periodic review

Experience Needed:
  • 4+ years of related experience in a pharmaceutical/ drug or medical device industry, or other FDA regulated industry
  • Working knowledge of cGMPs and ISO Standards preferred
  • Experience with administration of Learning Management Systems (LMS), Electronic Data Management System (EDMS) and Master Control required
  • Experience in Manufacturing and Quality positions, preferably both
  • Experience performing work that requires decision making and the consistent exercise of independent judgment and discretion
  • Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211;aseptic drug manufacturing experience a plus
  • 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
  • Public speaking, instructional presentation skills and/ or instructor-led training experience required
  • Must have a strong understanding of FDA and other cGMP regulatory requirements as they relate to industrial and non-industrial tasks at a biotech manufacturing facility and/or R&D facility
  • Must have excellent computer skills, including MS Word, PowerPoint and Excel
  • Experience with commercially available CBT authoring tools a plus

Meet Your Recruiter

Marion Bowden

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