Job Title: Sr QA Specialist (Pharma Product Release)
Date Posted: 04-29-2008
Job Location: California-San Francisco
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 7+ to 10 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Novo Nordisk Delivery Technolo
Contact Information: Novo Nordisk Deliver   Novo Nordisk Deliver (aknr@novonordisk.com)
Job Description:
Overview of Position

 

Act as the internal expert and lead for material and product related documentation issues to
support audits, investigations and release.  Coordinate daily activities to support t release
of clinical and research material and product.  Provide guidance to internal functional group
members as needed.  Work with minimal supervision to achieve goals.

 

Job Responsibilities

 

1.            Act as the internal expert and lead for material and product related
documentation issues to support audits, investigations and release.

2.            Coordinate daily activities to support t release of clinical and research
material and product.

3.            Oversee tracking and traceability databases for materials, batch records, etc.

4.            Review manufacturing batch records and supporting documents used for processing
product and in-process material to ensure compliance with internal documents and cGMP
regulations.

5.            Review raw material test reports to ensure compliance with internal documents
and cGMP regulations.

6.            Independently identify corrective actions on controlled documents and coordinate
revision process with other internal functional groups.

7.            Independently identify and address areas where cGMP violations exist, and
coordinate with other groups to resolve them.

8.            Interface with all internal departments to proactively identify potential issues
and develop solutions to minimize or prevent the adverse effect of the issue on project plans.

9.            Exhibit solid verbal and written communication skills to support leadership
activities and document generation.

10.        Perform internal investigations as needed.

11.        Represent QA on project sub-teams as needed.

12.        Provide guidance to internal functional group members as needed.

13.        Participate in the resolution of observations issued by partners, state, federal,
or other agencies as needed.

14.        Support other departmental activities as needed.

 

Required Qualifications

 

Minimum Education Typically Required: BS in a scientific discipline

 

Preferred Degree (if appropriate): N/A

 

Amount of Experience Typically Required: 7-10 years of QA related experience in the
pharmaceutical/biotech industry
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