Commercial GMP Quality Assurance Specialist
2 weeks ago
JOB DESCRIPTION:
Sound understanding of GMP principles and their application to product quality and compliance, supporting commercial paper-based Executed Batch Record (EBR) and disposition of Drug Substance (DS)/ Active Pharmaceutical Ingredient (API), Spray Dried Dispersion (SDD), and/ or Drug Product (DP). The ideal candidate will have a strong background in EBR review, disposition, Contract Development, and Manufacturing Organization (CDMO) experience and a background in biopharmaceuticals.
KEY RESPONSIBILITIES:
Include the following but are not just limited to:
Supports and/ or leads product quality investigations (manufacturing process, analytical, and operations), ensuring they are adequate and cGMP compliant.
Supports and/ or leads product and process change controls as needed.
Identifies and recommends appropriate CAPA as needed for investigations and evaluates CAPA effectiveness check.
Performs GMP document review ranging anywhere from Executed to Master Batch Records (MBR/ EBR), archival and may support process validation-related activities and documentation.
Supports collaborative efforts for and with audit and inspection teams.
Tracks and trends metrics that are product or process related as directed by the management.
Ensures risks are identified, communicated and critical issues are escalated, followed up through until addressed, and proactively assists with risk mitigation plans.
Works independently and meets timelines, objectives, and deliverables in principle.
Knowledge and Skills:
Able to support multiple projects/ cross-functional teams and members within stated objectives and timelines and collaborate effectively.
Effective communication skills with the ability to process, simplify, and communicate potentially complex information.
Ability to work independently even in challenging environments, think critically, support evaluation of product quality matters, and exercise sound judgment based on precedent, with rationale.
Sound understanding of cGMP manufacturing and testing principles, deviations, investigations, Root Cause Analysis (RCA), change controls, and CAPA in a pharmaceutical setting.
Ability to work on various document management quality systems.
Education and Experience:
Associate/ Bachelor’s degree in a scientific field with 2-5 or more years of relevant work experience and/or the equivalent combination of education and experience.
Experience providing commercial quality support and cGMP oversight of manufacturing operations, with an exclusive focus on batch release
Experience with DS/API, SDD, and DP small molecule (oral solid dosage forms preferred)
Knowledge of cGMP requirements governing oral drug products manufacturing practices
Pay Range:
$55-$60/HR
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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