Job Description
Position Summary: The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. The role requires maintaining quality systems and data generated by team members, contributing to investigations, and ensuring compliance with industry standards
Responsibilities: - Performs routine Bioanalytical testing and release of in-process, stability and REACT Final Product samples as scheduled
- Executes routine and non-routine analysis, including but not limited to raw materials, in-process items and finished product according to established operating procedures; may include:
- Flow Cytometry
- ELISA
- Kinetic Assays
- Cell Counting/Viability
- Visual Appearance
- Initiates and Supports Deviation/OOS investigations in MasterControl
- Initiates and Supports Action Item completion as assigned in MasterControl
- Initiates and Supports AQEM activities as assigned in Master Control
- Follows Test Methods (TSMs) Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols
- Authors originals, revisions, and training on TSMs, SOPs, WRKs, Test Forms, and Protocols
- Support QC Analytics with sample receipt from Manufacturing
- Trains and mentors incoming QC Analysts (all levels)
- Track and trend all QC Analytical testing performance of patient lot data along with critical reagent trending
- Maintain inventory levels in QC labs and coordinate material requests with Warehouse/Supply Chain
- Initiates, and participates in Change Control (MOC) management
- Authors/Initiates Aborted/Invalidated Assays in the QC Analytical Lab.
- Complete documentation accurately and in a timely manner
- Partakes in special projects on analytical methods and instrumentation problems related to execution of assays.
- Other duties as assigned
Minimum Qualifications: - Minimum of Bachelor’s Degree (or better) in chemistry, biochemistry, microbiology or related science
- 3-5 years’ experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry
- Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines
- Familiarity with bioassays, and raw material test methods
- Knowledge of LIMS systems
- Deviation Handling
- Change Control Management
- OOS Investigation experience
- Subject Matter Expertise in assays relevant to the QC Labs
- Strong communication skills with the ability to interact with various individuals
- Detail-oriented with problem-solving and decision-making abilities
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
Job Tags
Visa sponsorship, Work visa,