- 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.
- 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.
- Associate/ Bachelors 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
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Commercial GMP Quality Assurance Specialist - Boston, United States - Vertex Pharmaceuticals
Description
Job Description:
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:
Knowledge and Skills:
Education and Experience:
$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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