- 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.
- 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.
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QC Training Specialist - Philadelphia, United States - ProClinical
Description
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:
The QC Training Specialist will:
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) or .
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.
