Commercial GMP Quality Assurance Specialist
Found in: Resume Library US A2 - 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:
May include, but are not limited to, the following:
Identifies and supports quality investigations /deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
Ensures appropriate issues are identified, escalated, and are followed up until addressed.
Works independently and meets timelines, objectives, and deliverables in principle.
Performs GMP document review primarily EBRs and may support including Master Batch Records (MBRs), Validation Protocols, and Reports, as needed.
Identify and communicate risks and assist with risk mitigation plans proactively.
Minimum qualifications:
Knowledge and Skills:
Able to support multiple projects/ cross-functional teams and members within stated objectives, timelines and collaborate effectively.
Good communication skills with the ability to process, simplify, and communicate potentially complex information.
Ability to work independently in a fast-paced environment, 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), and CAPA in a biopharmaceutical setting.
Education and Experience:
Associate/ Bachelor’s degree in a scientific field with 0-3+ 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 exclusively 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
6 month contract initially, can be extended to 2 years. possibility to convert to full time.
Hybrid opportunity with 3 days on site required.
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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