QC Training Specialist

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.