Quality Assurance/Quality Control Specialist
Natick, MA • Full Time
Do you possess a bachelor’s degree in biological/biotechnology science or a related discipline and are looking for a new challenge?
HebeCell is a biotechnology company focused on translating cutting-edge stem cell technologies, looking to appoint a Quality Assurance/Quality Control Specialist to join our team. The successful candidate will be a key contributor to the implementation and execution of Hebecell’s quality systems including oversight of facility and equipment validation activities, responsible for the implementation of policies, practices, procedures, standards and systems necessary to ensure the compliance of site operations to global GMP regulations. The QA and QC Specialists report to the Associate Director of QA.
The key responsibilities of a Quality Assurance/Quality Control Specialists include, but are not limited to:
- Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
- Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
- Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
- Support the Quality approval of Master Batch Records.
- Supports the Quality review and closure manufacturing deviations.
- Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
- Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data
- Assist Manufacturing Operations by providing quality oversight and guidance for a typical
- Analyse chemical, biological, or microbiological products, raw materials, in process materials in support of the company’s Quality, Manufacturing, and Regulatory program.
- Performs environmental monitoring in cleanroom suites and qualitative tests or quantitative assays as needed.
- Interprets and evaluates results, identifies out of specification test results, and recommends corrective action where necessary.
- Reviews data obtained for compliance to specifications and report abnormalities.
- Compiles data for documentation of test procedures, review, and approval and archiving of documentation as required.
- Calibrates and maintains lab equipment according to calibration program.
- Basic laboratory and cleanroom housekeeping and maintenance of supplies.
- Participates in the preparation of investigations, summaries, and reports.
- Assists in developing QC testing methods and revising /updating standard operating procedures as needed.
- Perform special projects on analytical and instrument problem solving.
- Applies knowledge of GMP, GLP and GRP daily.
- Follows written test methods and protocols
HebeCell was founded in 2016 by a group of scientists who wanted to push research in regenerative medicine and immuno-oncology farther than ever before. Our team of researchers includes multiple world-leading experts in stem cell biology, as well as experienced entrepreneurs and business developers. We operate a fully-equipped, state-of-the-art laboratory in Natick, MA, one of the world’s largest biotech hubs.
Since 2016, we have grown HebeCell into a leading innovator in our field. HebeCell has recently raised $53 Million in Series A Financing to Advance its Unique Off-The-Shelf PSC-CAR-NK product into the clinic, targeting cancers, autoimmune and infectious diseases. We are primarily engaged in developing universal and cost-effective NK cell therapeutics based on its proprietary 3D-pluripotent stem cell (PSC) platform, the off-the-shelf NK cell products will be readily available to all patients worldwide. Most importantly, we have developed and patented a method of producing allogeneic natural killer (NK) cells indefinitely from induced pluripotent stem cells (iPS cells) by suspending them in a liquid solution within specially engineered bioreactors. No other company or lab has this technology or these capabilities.
- Medical, dental and vision insurance
- Matching 401(k) contributions
- Performance bonus
- Paid vacation, holidays and sick leave
- Life insurance
- Disability benefits and free workday lunch etc.
The key skills and qualities of a Quality Assurance/Quality Control Specialists:
- BS/MS Degree in a scientific discipline.
- 1-4 years of experience in a GMP pharmaceutical setting.
- 1-4 years’ experience in quality control. Formal GMP training.
- Knowledge and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines preferred.
- Preferably cell therapy products experience
If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please click the apply now button to find out more.
To apply, please submit your cover letter/ resume to: email@example.com