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System One Services Sr. Quality Assurance Associate - Pharmaceuticals in Baltimore, Maryland

Sr. Quality Assurance Associate - PharmaceuticalsBaltimore, Maryland

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Type:Contract

Category:Scientific & Clinical

Job ID:157632

Date Posted:11/18/2020

Title: Sr. Quality Assurance Associate, Pharmaceuticals

Location: Baltimore, MD

Duration: Contract

Schedule: M-F 40 hours

Target Start Date: 11/16/20

Responsibilities:

  • Prepares, reviews and issues required pharmaceutical quality documentation

  • Provides input on quality control procedures.

  • Provides oversight for the development and maintenance of pharmaceutical quality programs.

  • Provides expertise and guidance in interpreting pharmaceutical policies.

  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

  • Performs pharmaceutical batch / lot record review to ensure that all reviewed records have been executed per procedure.

  • Conducts investigations determine appropriate corrective actions, CAPA.

  • Investigates product complaints and conducts follow-up with customer.

  • Reviews executed commercial production records.

Requirements:

  • BS/BA or MS in Chemistry; or closely related field required

  • Quality Assurance experience for commercial Pharmaceutical Manufacturing.

  • Demonstrated experience performing batch record review

  • Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word, Excel, and Microsoft TEAMS)

  • Working knowledge of Trackwise desirable

  • Ability to work independently with minimal supervision and direction

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

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