GMP QA Operations Specialist - Marion, United States - Stark Associates LLC

Description

Job Description

Job DescriptionJob Role:
GMP QA Operations SpecialistLocation: Marion NCContract: W2Key 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 support to manufacturing operations at contracted
suppliers
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.
Supports maintenance of Quality Metrics to support on-time release deliverables
Supports drafting and revising Quality Agreements between CMOs/Suppliers and
Vertex, as needed Conducts GMP document review, including Master Batch Records, Executed
Batch Records, Validation Protocols, and Reports
Identify and communicate risks and assist with risk mitigation plans as
necessary.


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 perform an evaluation of quality matters and solve
straightforward problems using technical experience and judgment based on
precedent and applicable SOPs.
Demonstrated ability to evaluate internal and external excursions including
deviations, investigations, CAPAs, and change controls as well as performing
Root Cause Analysis (RCA),
Experience with batch record review and batch disposition activities for DS/DP
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 a minimum of 5 years of experience or the equivalent
combination of education and experience.
Experience providing Quality support of GMP manufacturing operations including
batch release.
Experience with small molecule (oral solid dosage forms preferred) development
and manufacturing with proficient knowledge in a pharmaceutical setting.
Knowledge of cGMP requirements governing small molecule manufacturing.