The QC Project Support Specialist will apply their expertise in the field of biological sciences to support a wide variety of QC related projects including but not limited to the design, development, implementation, execution, validation / re-validation and optimization of current and proposed analytical methodologies, oversight of process change orders (PCO), Corrective Action / Preventative Action (CAPA) investigations, Root Cause Analyses (RCA’s) as well as providing general support and direction to internal / external QC investigations, audits and risk management activities. The successful candidate will coordinate and manage projects for the validation of equipment, processes, analytical methodologies, cleaning procedures, instrumentation and computer related systems as well as provide support and direction to the QC Chemistry and Analytical Support team on an ongoing basis. The QC Project Support Specialist will ensure protocols, records and procedures are in compliance with the current Code of Federal Regulations (CFR) and current Good Manufacturing Practices (CGMP) amongst other regulatory governance and guidance’s such as the American Association of Tissue Banks (AATB), human cells, tissue and cellular / tissue based products (HCT/Ps), United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH). This position utilizes strong facilitation, problem solving, critical thinking and a can-do mind-set to ensure the continual improvement of quality systems and processes used to develop, manufacture and distribute safe and effective regenerative technologies that meet customer expectations and regulatory requirements.
The QC Project Support Specialist prepares, executes and summarizes validation protocols, reports and other related technical documents to support various projects related to equipment qualification, instrument qualification, test method validation, process validation, process change orders and CAPA’s as they relate to QC.
- Coordinates project related activities with plant support groups (Production, Calibration, Facilities, QC/QA, PD amongst other key stakeholders), for the timely execution of protocols and reports.
- Performs visual inspection of finished product.
- Coordinates or participates in development projects including laboratory, pilot or plant scale investigations / trouble shooting to provide improved procedures, equipment or processes for existing products and processes.
- Understands and operates basic equipment and technologies, as applicable to job function.
- Basic knowledge of descriptive statistics and acceptance sampling.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA.
- Complies with all company and site policies and procedures.
- Knowledge of Quality System and SOP procedures as well as industry regulations and standards such as CGMP, GLP, FDA, USP, ISO, ANSI and ASTM.
- Well versed in technical writing, GMP document control practices and familiarity with the authoring of SOP’s, validation protocols and reports as well as other technical reports and associated documentation which requires a keen ability to write creatively, technically and accurately.
- Knowledge of 5S Lean manufacturing principles and six Sigma is preferred.
- Knowledge of appropriate risk management tools such as FMEA.
- Efficient in experimental design and execution in compliance with regulatory agencies.
- Understands and executes cost reduction and productivity improvement tasks using Process or Design Excellence techniques.
- Minimum of B.S. in Biological Sciences, or Chemistry is required.
- 5-8 years of industry experience in the biological sciences.
- Supervisory experience is preferred
- GMP and FDA experience in the field of biologics and medical devices is preferred.
- Able to lift 50 lbs. and 40% of time standing in workday.