Vertex Pharmaceuticals
GMP Operational Quality Senior Specialist (Contract) 23758
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
The GMP Operational Quality Senior Specialist Contractor supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of activities and supports new/existing project initiatives. The GMP Operational Sr. Quality Specialist Contractor is recognized as a subject matter expert in the principles and application of quality assurance and compliance. The Sr. Quality Specialist Contractor coordinates GMP activities in support of commercial disposition. This position reports directly to the Senior Manager, GMP Operational Quality.
The ideal candidate will have strong experience/knowledge with
deviations, change controls and batch review.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
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.
Enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.
Assists Change Control owners with ensuring compliance to change procedure requirements.
Supports change control assessments, implementation, approval, and closure.
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. Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
Ensures appropriate CAPA actions are identified and addressed.
Approves investigations/CAPAs.
Maintains Quality Metrics to support on-time release deliverables.
Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports.
Identifies and communicates risks and assists with risk mitigation plans as necessary.
Identifies and facilitates continuous improvement efforts.
Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
Supports continuous improvement projects.
Minimum qualifications:
Knowledge and Skills:
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborating 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.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
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.
Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA.
Education and Experience:
Bachelor's degree in scientific or allied health field (or equivalent degree).
Typically requires 3 years of experience, or the equivalent combination of education and 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.
Pay Range:
$55-70/hr
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The ideal candidate will have strong experience/knowledge with
deviations, change controls and batch review.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
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.
Enforces Quality Agreements between CMOs/Suppliers and Vertex, as needed.
Assists Change Control owners with ensuring compliance to change procedure requirements.
Supports change control assessments, implementation, approval, and closure.
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. Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
Ensures appropriate CAPA actions are identified and addressed.
Approves investigations/CAPAs.
Maintains Quality Metrics to support on-time release deliverables.
Conducts GMP document review, including Master Batch Records, Executed Batch Records, Validation Protocols and Reports.
Identifies and communicates risks and assists with risk mitigation plans as necessary.
Identifies and facilitates continuous improvement efforts.
Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
Supports continuous improvement projects.
Minimum qualifications:
Knowledge and Skills:
Experience supporting multiple projects/teams within stated objectives and timelines.
Experience supporting cross-functional team members and collaborating 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.
Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
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.
Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA.
Education and Experience:
Bachelor's degree in scientific or allied health field (or equivalent degree).
Typically requires 3 years of experience, or the equivalent combination of education and 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.
Pay Range:
$55-70/hr
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