Pay Range: $30 - $32/hour

Position Details:

Industry: Pharmaceutical

• Experience with chamber and autoclave qualification/mapping
• Bachelor’s degree in biology, microbiology, engineering, or other technical/scientific area
• Knowledge of QA systems and GxP compliance requirements
• Ability to work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated, and qualified.
• Job Title: Specialist, Lab Services

• The Specialist, Lab Services may be responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations.? Specific areas of support may include: GMP/Compliance; Change Management; Lab Equipment/Instrument procurement, installation, calibration, validation/qualification; and other QC Lab support projects. This position will help to ensure that the QC Labs operate in compliance with Corporate and governmental regulations.
   

• Draft and execute IQ/OQ/PQ qualifications for temperature, temperature and humidity-controlled chambers, and autoclaves.
• Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated, and qualified. Ensuring each aspect of the process is compliant with Corporate and governmental regulations
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within the quality system.
• Support the QC Labs to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/ scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
• Strong oral and written communication skills.
• Good interpersonal skills

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)