Manufacturing Compliance Specialist

Location
Baltimore, MD, US
Posted
Apr 19, 2019
Ref
1466
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Manufacturing Compliance Specialist writes, issues, maintains and follows batch records lifecycle throughout the manufacturing plant. Once documents have been created and approved, the incumbent will be responsible for tracking the lifecycle of batch records and documents to support manufacturing activities. This position also writes and reviews standard operating procedures (SOPs).

Key Responsibilities:
  • Responsible for creating documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility
  • Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation
  • Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available
  • Tracks GMP review and production close out of batch record documentation
  • Key contact with Quality Assurance to ensure robust and stable document flow from issuance to archiving
  • Positively interacts with internal associates to quickly and effectively resolve issues
  • Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives
  • Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc.
  • Develops processes for batch records including for issuing, tracking and reviewing batch records
  • Develops and maintains metrics to track batch record turnaround time, errors and document related deviations

Education / Experience:
  • Bachelor's degree in Life Science, Chemistry or Engineering
  • 5 years of broad cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
  • Extensive experience with GMP documentation management for biologics


Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.