Clinical and Health - Project Specialist I

Job-ID Reference QA Specialist Based at 1011 N Arendell Ave, Zebulon, NC 27597, 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.

The responsibilities include some of the following: • 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 Basic Qualifications: • 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) Preferred Qualifications: • 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 EEO: “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”