QA Specialist
Integrated Resources
Title: Project Specialist/QA Specialist
Location: Zebulon, NC 27597
Duration: 12 Months+
Shift: 1st Shift, 8am to 5pm Notes :
Location: Zebulon, NC 27597
Duration: 12 Months+
Shift: 1st Shift, 8am to 5pm Notes :
- The role requires to be onsite at the Zebulon facility 5 days per week, working 40 hours per week.
- This is a first-shift position with working hours from 8:00 a.m. to 5:00 p.m.
- Ensuring quality and compliance of Investigational Medicinal Products used worldwide.
- Serve as a Batch Release Officer for the review and recommended release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP requirements.
- Assessment of Quality QMS Records (e.g. Deviations and third party or internal complaints), make recommendations for corrective and preventative actions and to follow up on the implementation of those recommendations.
- Review and Approve GMP documentation, which may include
Standard Operating - Procedures, Change Controls and other controlled documents from business partner areas such as Clinical Supply Chain packaging operations and logistics
- Provide advice and support to business partner areas relating to quality matters and process improvement.
- Develop and incorporate effective processes and procedures in Quality R&D Supply QA/QP US and may contribute to business processes and procedures outside of quality
- May participate in Audit/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
- Participate in or lead improvement initiatives.
- Bachelor's degree or equivalent work experience such as 5+ years in similar position
- Experience of QA review of GMP Manufacturing and/or Packaging Documentation
- and/or laboratory records of pharmaceutical dosage forms which may include sterile
- products and/or review and approval of GMP documentation within a Quality Assurance/Quality Control role.
- Experience of knowledge of GMP principles and being a decision maker using this knowledge.
- Experience leading or participating in QMS activities (e.g. Quality Deviations, third party/Internal Complaints, Change Controls and inspections/audits and root causing)
- Proficient working knowledge of Microsoft Windows suite of applications (Word, Excel, Power Point)
- Experience working in high pressure environments where there are likely to be conflicting priorities
- Knowledge of the R&D process , particularly with respect to clinical trials manufacturing and packaging.
- Strong attention to detail
- Good communication skills with the ability to build relationships and trust; and make decisions based on GMP principles, problem solving and collaboration.
Vacancy posted 8 hours ago
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