QC Training Specialist

Highly Competitive Salary
  1. Permanent
  2. Biochemistry, Genetics & Genomics, Molecular Biology
  3. United States
Philadelphia, USA
Posting date: 03 May 2024

QC Training Specialist - Permanent - Philadelphia, PA

Proclinical is seeking a dedicated QC Training Specialist. This is a permanent position located in Philadelphia, PA.

Primary Responsibilities:

This role focuses on establishing a comprehensive training program and certification requirements for all Quality Control (QC) Teams. The successful candidate will be responsible for developing, conducting, and revising a QC training program, ensuring compliance with all relevant procedures, standards, and GMP regulations.

Skills & Requirements:

  • Experience working in Biopharmaceutical or Pharmaceutical industry in Cell and/or Gene Therapy preferred.
  • Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 5-10 years of experience in biopharmaceutical based GMP operations.
  • Experience successfully working in an analytical role/level
  • Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
  • Solid understanding of Quality systems
  • Proficiency in basic and advanced analytical methodologies within a functional laboratory
  • Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays
  • Solid understanding and functional knowledge in Flow Cytometry, Microbiology assays, cell counts, and/or potency assays
  • Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
  • Experience, training, or certification with Process Excellence tools and methodologies
  • Experience with Quality Control document reviews and regulatory inspection processes
  • Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
  • Proficiency with Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint)
  • Requires ability and flexibility to work or support multiple shifts and provide occasional support on the weekends, as needed.
  • Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced team-oriented environment.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent oral and written communication skills. Strong technical writing ability required.

The QC Training Specialist will:

  • Identify training needs, devise an organizational training strategy and curriculum, oversee its implementation, evaluates effectiveness through competency testing, and establish a feedback loop to ensure continuous improvement.
  • Develop a training schedule, coordinate the staffing and scheduling of in-house and field training.
  • Plan curriculum design and support documentation, including drafting and approval of SOPs.
  • Training and development of staff, including mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
  • Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
  • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of training.
  • Establish key performance indicators to measure training effectiveness.
  • Create processes that enable timely and actionable performance feedback of trainees.
  • Develop a comprehensive understanding of current production process, as this role is viewed as a subject matter expert within specific area.
  • Ensure the department understands and complies with quality standards and requirements as documented.
  • Must adhere to our core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.