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Development Quality Assurance Associate

Company: System One
Location: Durham
Posted on: November 23, 2021

Job Description:

Job title: Development Quality Assurance Associate
Hours: 8 AM- 5 PM M-F
Duration: Direct Hire
Location: Durham, NC

MUST HAVES:
Bachelor's Degree in any science related field
Must have experience with cGMP
Required experience with HPLC and GC Analytical testing
Required experience with Empower 2 or 3 software review
Required Analytical Testing Review Experience
Required experience with Analytical Method Qualification and Validation with knowledge of required studies for either.
Minimum 2 years working in a Pharmaceutical cGMP environment
Knowledge of Microsoft Office Systems
Pharmaceutical background, esp. in Analytical R&D preferred (Generics preferred, but not mandatory)

Responsibilities:
This position will be responsible for all controlled documents at NC R&D, Aurobindo Pharma USA. This position will be responsible for reviewing/approving all Analytical method Qualification/Validation protocols, raw data and reports. This position will also be responsible for review of Development batch records and associated documentation. This position will be responsible for developing and optimizing current cGMP document systems. They will oversee the training records for the R&D team. Assist in preparing company quality metrics as well as any document related tasks as they are necessary.
Responsible for reviewing and maintaining the Company SOPs, training, Analytical method validations, specifications, investigations, deviations and CAPA systems in an orderly and secure manner
Assure all R&D SOPs and Controlled Documents are in "current" status
Review and approve all Developmental Batch Records and all associated documentation Aiding in reviewing/approving equipment qualification documentation and internal calibrations
Issuance and Recollection of controlled documentation Aiding in training activities
Assisting with Government Agency Inspections

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.

Keywords: System One, Durham , Development Quality Assurance Associate, Other , Durham, North Carolina

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