US - Quality Assurance
: Job Details :

Job DescriptionClient: Brevitas Corp.Our Global Company, Brevitas Corp., is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change. Weserve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage, Chemicals, and Information Technology.We are looking for a highly motivated and energetic individual to join our team as a Quality Assurance for our pharmaceutical client based in Raleigh, NC.This job is in the United States and only candidates eligible to work in the U.S. for any employer will be considered.By applying to this job, your profile will be considered for upcoming roles within the next 1-6 months when opportunities do arise.Most of these opportunities will include ON-SITE work and contract term length.Responsibilities:

• Review and approve master production records for the timely initiation of GMP manufacturing activities
• Review executed batch records and related documentation, resolve compliance issues and dispositions lots of drug substances, bulk drug product, drug product and clinical materials for use in clinical trials
• Participate in vendor meetings for raw materials, excipients, cell banks and plasmids
• Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations
• Ensure that all requirements, as stipulated in the appropriate Quality Technical Agreement have been met
• Issue & Review documentation, including (Deviations, CAPAs, OOS, etc.)
• Write and revise SOP, forms, WI, and any other document types
• Assist with internal and external audits
• Compile data analysis and metrics for Quality management review, KPIs etc.

Qualifications:

• Bachelor's or Master's degree in Biotechnology or relevant Science field.
• Various levels of experience will be considered (Including junior, intermediate, and senior levels)
• Experience working in a GMP manufacturing, QA or QC environment within pharmaceutical/biotechnology industry
• Experience with outsourced manufacturing and testing lab operations an asset

To Apply:

• Click the I'm interested button below, or
• E-mail your resume in MSWord or pdf format to ...@brevitascorp.com with the following details in the e-mail's Subject Line: US - Quality Assurance: FIRST NAME, LAST NAME.

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