QA Specialist job in Waltham, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Waltham, MA.

Job Responsibilities:

Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.
Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.
Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.
Clearly communicate issues as applicable to CMOs and Quality management in a timely basis
Review and approve documentation related to production and / or packaging operations as assigned.
As appropriate attend project meetings.

Skills and Requirements:

Minimum bachelor's degree in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science)
Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies)
Experience and working knowledge on Small molecules chemistry, tablets and capsules.
Experience building relationships and working with CMOs
Working knowledge ICH/EMA/FDA regulations
Competency in MS Office, Adobe Acrobat, Veeva, Trackwise

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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