The Quality Control Training Specialist II is responsible for establishing a formal training program and certification requirements for all QC Teams. The Training Specialist II is responsible for developing, conducting, and revising a QC training program on the methods used in the laboratories (Flow, EM, potency assays, etc.). They are responsible for ensuring training is completed in compliance with all applicable procedures, standards, and GMP regulations.
Essential Functions and Responsibilities • 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 companies 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.
Required Education, Skills, and Knowledge • 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.
Preferred Education, Skills, and Knowledge • Experience working in Biopharmaceutical or Pharmaceutical industry in Cell and/or Gene Therapy preferred.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.