Agc Biologics - Boulder, CO

posted 3 days ago

Full-time - Mid Level
Boulder, CO
1,001-5,000 employees
Chemical Manufacturing

About the position

The Manufacturing Supervisor, Technical Writing is responsible for overseeing the daily operations of the Manufacturing Technical Writing team. This role includes managing personnel, planning project priorities, ensuring compliance with established processes, and supporting the team in delivering high-quality documentation and project deliverables. The supervisor will also represent the team in various meetings and drive operational improvements within the manufacturing and technical writing functions.

Responsibilities

  • Maintain a safe work environment.
  • Plan priorities for Technical Writers related to procedure and document management.
  • Ensure all Technical Writing team project timelines are maintained.
  • Support the Technical Writing team in completing project deliverables including GMP document generation/revision, CAPA/CR closure, training, and process improvements.
  • Ensure compliance with company quality systems, safety procedures, and other company policies.
  • Provide training, mentorship, and coaching to staff within the Technical Writing team.
  • Represent Manufacturing and Technical Writing teams at internal and external meetings.
  • Work closely with Manufacturing and Quality Assurance to drive timely closure of quality records.
  • Provide direction to employees according to established policies and management guidance.
  • Prepare and deliver routine reports and communications to site regarding document status.
  • Participate in and lead operational improvement projects for Manufacturing operations and the Technical Writing team.

Requirements

  • BS in scientific discipline such as Biochemistry, Chemistry, Biology, or related discipline required.
  • Minimum of 5+ years of GMP biotechnology/pharmaceutical industry experience required.
  • Operational expertise of GMP biotechnology/pharmaceutical industry processing equipment required.
  • Previous supervisory experience or experience leading teams is required.
  • Experience using quality management systems software and project management tools required.
  • Operational knowledge of cGMP regulations required.

Nice-to-haves

  • Strong problem-solving skills.
  • Strong technical writing and communication skills.
  • Strong computer literacy required (e.g. QMS such as TrackWise, MS Office Suite, etc.).
  • Ability to don required garments and work in cleanroom environments as needed.

Benefits

  • Highly competitive compensation package
  • Friendly, collaborative culture that values personal initiative and professional achievement
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