Quality Control Analyst

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.