Clinical and Health - Project Specialist I

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.