Quality Control Analyst
Raleigh Metro Area, NC
Primary responsibilities for this position include performing tasks associated with general cell culture, release testing and documenting laboratory data.
The analyst will be responsible for ensuring that the samples are collected and tested and reviewed according to quality requirements and results reported are valid, accurate and documented per applicable regulatory and corporate requirements.
Perform general mammalian cell culture, cell culture support activities, and cell culture based safety testing in support of manufacturing operations
Perform general molecular biology based procedures including DNA and RNA extractions, QPCR, RT-QPCR, PCR labelling and detection reactions, and PCR-based safety testing in support of primary and secondary operations
Performs routine testing and associated tasks without errors per applicable SOPs and protocols. Maintains equipment
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
Participates in cross-training to support staff availability within QC department
Performs shift-work including some weekend work as necessary to support manufacturing operations.
0+ years of related laboratory experience OR equivalent.
Knowledge of laboratory practices and instruments required.
Experience with cell culture techniques and LIMS preferred
Knowledge of GMPs, safety regulations and data integrity preferred.
Bachelor s degree in Scientific discipline or associate s degree and 3+ years of industry experience or equivalent.