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Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Georgetown, SC

Medical Director
Eagan, MN

Director Regulatory Affairs
Eagan, MN

Miami, FL

Our Clients
Job Id A8E828 
Location FL
  • Responsible for routine presence in the cleanroom to perform quality oversight of product processing and manufacturing in accordance to GTP & GMP requirements as well as for orienting, training and overseeing product processing and manufacturing from a quality perspective; Train and be competent on performing activities conducted in the cleanroom such as scrubbing/gowning/gloving, aseptic technique, product processing and manufacturing in order to adequately oversee these activities from a QA/QC perspective.  
  • Responsible for quality control functions to support production activities in the Good Manufacturing Practices (GMP) facility such as reviewing equipment Operational Qualifications (OQ), review and approval of environmental monitoring data, daily review of cleanroom monitoring data, and QA review and approval of production records.  
  • Responsible for working with Production to ensure that facility use, aseptic technique and manufacturing processes comply with GMP requirements and the written guidelines outlined in SOPs and associated documents.
  • Detect and report potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • Participate in discrepancy, nonconformance, and error/deviation detection, investigation and resolution.
  • Responsible for documentation related to production as required in a GMP environment to include writing process and product validation protocols and reports, preparing planned deviation requests, change control documentation, conducting error/deviation investigations, preparing corrective and preventive action reports, performing SOP verifications, writing and updating SOPs, and the preparation of material and quality specifications for raw materials used for production.
  • Identify potential improvements to Quality Systems and procedures gaps, and implement improvements as directed.
  • Provide guidance and coaching in the application of cGMP throughout Quality operations.
  • Participate in internal and external audits and regulatory inspections.
  • Review and approve proposed changes to systems, procedures, and records.
  • Receive and provide training, as related to the above activities.  Perform competency assessments of production staff as per quality system requirements.
  • Participate in collaborations to support complex and/or multi-disciplinary projects.
  • Responsible for other duties and projects as assigned to support Quality activities.
  • Education - Bachelors Degree in Biological, Chemistry, Biochemistry Science or related field.
  • Experience – At least three years experience in a GMP/GTP environment; Experience working in a cleanroom environment; Experience in aseptic processing of tissue or cell products required; Knowledge of cGMPs/cGTPs required; Solid a understanding of GMP, FDA and ISO regulations; Ability to interpret and relate Quality Standards for implementation and review; In-depth knowledge of commonly-used concepts, practices, and procedures within a biotechnology/scientific field.
  • Skills - Ability to make sound decisions about managing priorities; Ability to communicate clearly and professionally both in writing and verbally; Excellent interpersonal communication skills; Flexibility in problem solving, providing direction and work hours to meet business objectives; Highly organized, detail oriented, motivated, and flexible;  Able to be proactive and work effectively and consistently prioritizing tasks to meet deadlines.
  • Fluent (oral/written) English.
  • Computer Proficiency – Outlook, Word, Excel and PowerPoint
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