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.
Principal Responsibilities
- 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.
Competencies:
- 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.
Organizational Relationship/Scope:
- Reports to Quality Control leadership team.
- Work is performed within a team of QC Analysts.
- Regular communication with QC, manufacturing, technical operations among others.
Working Conditions:
- 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
All your information will be kept confidential according to EEO guidelines.
