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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

Review executed API, drug product and packaging batch records
Review deviations/investigations related to API and drug product manufacturing as well as packaging
Assist with disposition of clinical products in multiple phases of development
Review change control documentation associated with API
Assist with reviewing API manufacturing validation documentation
Assist with other QA duties such as development of the Quality Management System

Skills and Requirements:

S. degree in life sciences, chemistry or equivalent and 5+ years GMP quality experience in a virtual Pharmaceutical/Biotech setting
Experience with small molecule and solid oral dosage forms required
Experience in early phase development transitioning to registration and commercial
Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations
Flexibility in handling workflow in a multi-tasking environment
Excellent oral and written communication skills for effectively interfacing with all levels of management and departments internal and external to the company
Ability to effectively prioritize and manage multiple projects and tasks
Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
At home in a results-driven, highly accountable environment where you can make a clear impact
A team player, who listens effectively and invites response and discussion
A collaborator who communicates in an open, clear, complete, timely and consistent manner

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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