Quality Specialist/Generalist

# of Openings
Direct Hire


This role is responsible for supporting the core quality systems, including investigation/deviation management, general and internal audit CAPA tracking, change control, risk management, compiling, trending and reporting key quality metrics for Senior Management review, tracking internal audit CAPAs, and other quality system functions, as needed. Works in a fast-paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product.


Administer Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution

  • Administer the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments
  • Perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions
  • Administer the change control system for tracking and coordinating the initiation, execution, and completion of change controls
  • Administer the Risk management system and track completion of risk assessments
  • Compile pertinent QA metrics for Senior Management review
  • Assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items for completion
  • Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials
  • Work with clients during initial and subsequent manufacturing campaigns
  • Conducts review of batch documentation for accuracy and completeness, documenting deviations and/or failure investigation, as appropriate
  • Maintains databases and systems used for tracking various GMP manufacturing associated support activities
  • Assists with the generation and/or revision of GMP documentation such as standard operating procedures
  • Support regulatory (FDS, EMA) and client audits/inspections of the company
  • Assists with performing internal audits
  • Works closely with manufacturing, Facilities, and Quality Control staff to resolve quality issues with regard to the facilities and product manufactured
  • Work closely with other departments at the organiation and offer assistance as needed
  • Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
  • Other duties as assigned
  • Skills & Technical Expertise:

    • Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
    • Exposure to applicable biological regulations (21 CFR Part 600s) or EU GPs, a plus
    • Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel
    • Ability to quickly learn and navigate new electronic systems
    • Able to work in a team setting and independently under minimum supervision
    • Ability to work in fast-paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product Experience supporting Federal government contracts is a plus
    • Creative individual with excellent troubleshooting skills
    • Requires the ability to produce results in a fast-paced environment to meet client deadlines


    • Work independently under general supervision to meet company goals

    Measurement of Performance:

    • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
    • Timeliness and accuracy in completion of projects and paperwork (quantity of work)
    • Contributions to projects beyond general responsibilities (quality of work)
    • Identification of problem areas affecting operations (knowledge/problem solving)
    • Offers suggestions for correcting problems and for improving operations
    • Exercises good judgment in dealing with operational problems
    • Understanding of theory, rationale behind tasks performed
    • Demonstrated understanding and adherence to company policies, safety procedures and the cGMPs
    • Ability to succeed in a team-oriented environment under very dynamic conditions


  • Requires a Bachelor's Degree in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation)
  • Requires 5 - 8 years of quality pharmaceutical experience with oversight provided to Manufacturing Operations, QC, and other cGMP areas.



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