QA Specialist

QA Specialist

02 Nov 2022
North Carolina, Raleigh / durham / CH, 27601 Raleigh / durham / CH USA

QA Specialist

Job Duties & Responsibilities

QA support and oversight of cGMP manufacturing, packaging, and analytical activities.
Ensure quality system excellence, including change control governance.
Ensure quality operations support for R&D projects, and R&D-to-commercial transition.
Key contributor to quality and technical aspects of ANDA site transfer into owned and 3rd party facilities.
Support all regulatory filings and required reporting.
Responsible for, or supporting one or more key programs and functions such as Annual Product Review, Investigations, batch record review, label management, product complaints, process improvement, cGMP training, etc.

Essential Qualifications

Minimum of 3 years of experience in a cGMP Quality environment and in a relevant QA Technical Leadership role.
Generic pharmaceutical manufacturing and QA experience is a MUST.
Thorough knowledge of cGMPs and relevant regulatory requirements.
Knowledge in change management, especially for ANDA technical site transfers.
Superior interpersonal and communication skills (verbal, written and presentation).
Highly ethical and transparent, with professional sensitivity and care for confidentiality.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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