Quality Control Analyst II

Job Description

Job Summary:

• This position supports the execution of routine testing in the Quality Control Analytical Chemistry laboratory, including chemistry assays associated with Incoming Quality and Raw Materials.
• This position requires proficiency and understanding of the theory related to processes, assays, and equipment, as well as the ability to identify issues/trends.
• The candidate filling this position will work to ensure tasks are completed in a timely manner, while strictly adhering to Client policies and procedures and cGMP.

Duties and Responsibilities:

• Perform QC testing while strictly adhering to Client policies and safety procedures, SOP/SWI, Pharmacopeia, Federal Regulations, cGMP, and required training curricula.
• Perform all scheduled activities defined by laboratory management to meet demands of Production, Method Development, Validation, Independent Demand, and Stability program.
• Maintain safety and compliance of the laboratory work area.
• Perform cleaning of laboratories, equipment, and ancillary areas as required.
• Prepare for and operate QC equipment including pre and post-run setup and maintenance.
• Complete required paperwork and documentation as required.
• Troubleshoot sample discrepancies.
• Perform peer proofing on assays.
• Develop a working knowledge of appropriate compendia and/or regulatory guidance.
• Attend/contribute to scheduled team meetings, department, and safety meetings.

Specific tasks may include:

• Raw material testing (pharmacopeia/wet chemistry assays).
• Water testing (TOC and Conductivity analysis).
• pH testing for media.
• Buffer assays (titrations and photometric methods).
• Analytical equipment setup, usage, and maintenance.
• Sample preparation and disposal.
• Coordination of contract laboratory testing.
• Chemical handling required with appropriate PPE provided.
• Vaccinations and vision examinations may be required based on specific job function.

Requirements:

• Bachelor’s degree in Chemistry or equivalent.
• 2-4 years of relevant experience in cGMP controlled/pharmaceutical industry.
• Exceptional attention to detail and strong writing skills are crucial.
• The candidate must be able to work in a dynamic team environment with flexible schedule, including potential for weekends/holidays.