QC Engineer I/II
Job Req code: 945
Category: Quality Systems
Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.This junior level QC Engineer will support both internal and external customers to Quality Control contributing to design and execution of qualification/validation protocols as well providing engineering input to QC and Corporate projects to ensure compliance with CGMP and applicable regulatory requirements. The candidate will be responsible for routine testing and visual inspections as well as assisting with the management of various Quality Control systems with the goal of sustaining the stability, cleaning, and dose audit programs in a current and compliant state. This position utilizes strong facilitation, problem solving, and customer service mind-set to help improve performance through process improvement/maturation.
- The QC Engineer prepares, executes and summarizes validation protocols and other related documents in support of various projects relative to new test methods and bioassays, including laboratory instrumentation.
- Contributes to project teams developing and executing testing strategies for process validations in preparation for submission to FDA and other regulatory authorities.
- Assist in designing, executing, and managing GMP studies related to sterilization validations and dose audit, extractable/leachable analysis, biocompatibility, and manual/automated cleaning.
- Assist in maintaining various Quality Control programs in a compliant state such as the raw materials and final product stability and manual cleaning programs.
- Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of assigned product or component.
- Coordinate validation activities with plant support groups (Operations, Maintenance, Technical Services, Quality, etc.) for timely protocol executions Participate in the rotation for visual inspection of finished product.
- Help coordinate Corporate development projects including laboratory, pilot plant or plant scale investigations to provide improved procedures, equipment or processes, test methods for existing products.
PREFERRED EDUCATION AND EXPERIENCE
- B.S. in Chemical Engineering, Biomedical Engineering, Biotechnology, or equivalent technical discipline required.
- 1-3 years of experience from within the biotechnology, pharmaceutical, or medical device industry preferred
- CGMP experience within a highly regulated environment a plus.
- Able to lift 50 lbs. and stand more than 50% of time during a regular workday.
KNOWLEDGE & COMPETENCIES
- Comfortable operating laboratory instrumentation and performing routine release testing (e.g., thermal analysis, mechanical testing, bioassays, analytical assays, etc.) with strong aptitude for learning and integrating new technologies.
- Fundamental knowledge of statistical techniques for data analysis and sampling strategies.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply 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, and/or ISO.
- Working knowledge of risk management tools such as FMEA.
- Identifies cost reduction and productivity improvement opportunities to elevate operational efficiency and overall excellence.
- Highly organized and detail oriented with aptitude for critical thinking and managing multiple and changing priorities
- Highly motivated self-starter with a passion for learning who works well both independently and as part of a team.
- Good oral communication skills with strong technical writing ability
- Highly proficient in Word, Excel, PowerPoint, and/or other data management systems.