The Quality Control (QC) Analyst will work both independently and within a team to perform daily analysis of in-process samples, finished product and raw materials via established test methods while following cGMP and GDP in the QC laboratory. Typical analysis consists of pH, Osmolality, ELISA, PCR, Sterility, UV/Vis spectroscopy and other general chemical and bioanalytical assays.
Conducts routine analysis of in-process samples, finished products, and raw materials according to standard operating procedures (SOPs) and Master Specifications.
Utilizes proper aseptic technique during the execution of analysis.
Performs stability testing according to established schedules.
Documents and investigates any OOS results.
Follows cGMP and GDP to perform all tasks.
Documents and assesses data against established specifications.
Perform inventory, stock and clean QC laboratories.
Perform QC review of data records.
Department specific/Non-essential responsibilities:
Assist with calibrating and maintaining laboratory equipment.
May perform training of new and existing QC team on established methods and procedures
May provide technical expertise for method optimization, verification, qualification, and validation.
May develop and qualify testing methods and SOPs.
May assist with or lead QC projects for process improvements.
May draft reports, plans and protocols.
May revise and updates SOPs.
Additional duties as assigned.
Experience / Skills:
Bachelor's degree in a scientific discipline or equivalent and a minimum of three years' related experience required.
Knowledge of cGMP is required.
Must possess skills and knowledge of general chemical and bioanalytical test methods.
Knowledge of ELISA, PCR, UV/Vis spectroscopy, cell culture and aseptic technique is preferred.
Experience with stability testing programs is preferred.
Attention to detail: able to organize and maintain data and information.
Ability to work in a controlled environment with gowning/PPE requirements.
Ability to learn through observation and hand's on experience.
Ability to work independently in a fast-paced, team oriented organization.
Strong written and verbal communication skills.
Reports to Quality Control leadership team.
Work is performed within a team of QC Analysts.
Regular communication with Quality, Manufacturing, Technical Operations among others.
70% laboratory and manufacturing environment
30% normal office and meeting room conditions
Must be able to perform work while aseptically gowned with the appropriate PPE