Job Description

Quality Control Analyst needed!

Summary:

A good understanding of QC test methods and raw materials release requirements per USP and EP compendia, is desired. Experience working in a GMP-regulated environment is essential. The position will report to the Supervisor – Raw Materials.

Shift is M-F, 2nd shift (3pm – 11:30pm)

Essential Functions and Responsibilities:

• Perform and support day-to-day activities for raw material release operations, including Acceptable Quality Level (AQL) sampling and inspection, Carbon Dioxide (CO2) sampling and testing, and other raw material releases.
• Support all quality events and tasks associated to raw material release.
• Author, review, and/or execute SOPs, protocols, reports, specifications, and other quality control documents as applicable.
• Support raw materials vendor qualification program.
• Support efforts in on-going readiness for regulatory inspections and compliance audits.
• Participate in investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
• Support problem solving for technical issues, pertaining to raw material testing and release.
• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
• All duties are performed with supervision and oversight.

Required Education, Skills, and Knowledge:

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
• Minimum (3) years in a GxP regulated setting (pharmaceutical or biotechnology industry)
• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
• Strong analytical and technical background in compendial testing and related equipment, including microbiology, potency, gel electrophoresis, wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC methodologies.
• Experience in raw material inspection and testing practices.
• Experience with quality events, including OOS investigations.
• Strong technical background and familiarity with laboratory control operations and quality systems.
• Experience with lab and data management systems (LIMS, Empower, Phenix).
• Broad knowledge of biological drug development with respect to Quality Control.
• Demonstrated ability to communicate with external partners with respect to quality control activities.
• Extremely detail-oriented with strong analytical, written, and verbal communication skills.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Demonstrate sense of urgency; ability to recognize time sensitivity.
• Flexible and adaptable style with an eagerness to take on challenges.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
• Problem solver who not only identifies issues but leads efforts to resolve them.

Preferred Education, Skills, and Knowledge:

• Experience with cell and/or gene therapy products is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate Personal Protective Equipment (PPE), i.e. safety glasses, shoes, vest.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use 20/20 near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 25 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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