Quality Analyst II
Perform testing on incoming materials, finished products and stability studies in QC Laboratory. Work in both lab and warehouse areas. May be trained as fork truck operator.
Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some supervision required.
Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
Utilize a range of electronic systems such as LIMS and document/equipment management software.
Author SOP changes; participate in change controls, CAPAs and other quality systems.
Resolve routine problems by utilizing appropriate resources. Assist in investigations.
May assist on special projects as needed. Help with continuous improvement.
Working hours: 8:00 AM - 5:00 PM
Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
Testing also includes visual inspections, dimensional verifications and analytical testing.
Additional materials tested include components, printed materials and chemicals.
Group is additionally responsible for raw materials, chemical sampling, the release of materials, retaining inventory, and stability setup and pulls.
Typically requires 1-3 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous experience preferred.
Requires a BA/BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience.
Some non-routine travel may be required.
Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions.
Must be able to lift 50 lbs.
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