Project Coordinator - Quality Agreements job in North Chicago, USA

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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*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Administrative, General Management, Project Management

Location: United States

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

Proclinical is seeking a Project Coordinator - Quality Agreements located in North Chicago, IL with a leading biopharmaceutical company.

Job Responsibility:

Interpret, explain and apply the applicable current GMP/GDP regulations, guidelines, policies and procedures
Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
Manage processes for the timely QA writing/review/approval of Quality Agreement related policies, processes, procedures, templates, and other documentation
Identify, lead / facilitate process improvement and efficiency projects pertaining to GxP Compliance within R&D and between R&D and Operations or Third Parties
Collect, analyze and report metrics pertaining to GxP Compliance
Support audit activities with respect to Quality Agreements and other Quality System elements, responding to audit requests, subject matter expert resource
Effectively communicate audit results, both orally and in writing. Review corrective action plans / audit responses for adequacy and approve if adequate.
Review GxP Service Provider business contracts/agreements and related documents for Quality related subject matter to ensure compliance with current regulations/guidance/industry standards

Skills and Requirements:

Bachelor's degree; preferred in physical science, life science, pharmacy, business, or engineering. Minimum 5 years total combined experience required related to the following (not the sum or):
- 7+ years' experience in Quality Assurance
- 5-7 years' experience in Quality Assurance / Regulatory Affairs (Pharmaceutical preferred)
- 5-7 years' Clinical Research Development / Manufacturing, finishing or analysis of investigational drug supplies
Technical document writing skills
Interpersonal communication skills (written and verbal)
Negotiation skills with internal and external partners
Teamwork skills (ability to lead/facilitate multi-functional project teams
Ability to manage several projects simultaneously

If you are having difficulty in applying or if you have any questions, please contact Kate Heffernan at (+1) 610-624-3327 or K.Heffernan@proclinical.com.

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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