GMP Operational Quality Sr. Specialist (Contract) 499

Atrium Works • Boston, MA

5d

About The Position

The GMP Operational Sr. Quality Specialist is recognized as a subject matter expert in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of commercial disposition. This position reports directly to Senior Manager, GMP Operational Quality. The ideal candidate will have experience in QA and be familiar with review/approval of Investigations, Deviations, Change Controls and CAPAs. Small molecule analytical testing is a plus and any analytical experience before transitioning to QA (compliance).

Requirements

• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
• Experience supporting multiple projects/teams within stated objectives and timelines
• Experience supporting cross-functional team members and collaborate effectively
• Good communication skills (written and verbal) and the ability to exchange potentially complex information
• Able to integrate activities with other groups, departments and project teams as needed
• Bachelor’s degree in a scientific or allied health field with 3+ years of relevant work experience.
• Experience providing Quality support and oversight of GMP manufacturing operation including batch release
• Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
• Knowledge of cGMP requirements governing oral drug products manufacturing practices

Nice To Haves

• Small molecule analytical testing is a plus
• any analytical experience before transitioning to QA (compliance)

Responsibilities

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Vertex or at contracted suppliers
• Drafts and enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Assesses and approves change controls
• 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 CAPA actions are identified and addressed.
• Approves investigations/CAPAs.
• Identify and facilitate continuous improvement efforts
• Maintains Quality Metrics to support on time release deliverables
• Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports
• Performs disposition activities in support of Commercial Stability products
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Manages audit CAPAs & metrics

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• eligible for overtime pay, in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Senior