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The Opportunity
Description
We're looking for a
QA Interim Manager, working in
Pharmaceuticals and Medical Products industry in
6397 Kaiser Drive, Fremont, California, 94555, United States.
- Plans and manages the work of the BI Fremont Quality
Assurance group overseeing Quality Control.
- Provides technical expertise on Quality Assurance standards.
-
Identifies deviations from SOPs in Quality Control operations; records and
reports issues to appropriate parties; recommends corrective action and follows
up to ensure resolution.
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Supports QA Disposition by review and approval of QC disposition elements (test
record reviews, CofA approval, CofC, EM assessments etc.
-
Reviews approval of QC Standard Operating Procedures and Change Controls to
ensure compliance with cGMP requirements.
-
Reviews approval of method transfers, method qualifications and QC
protocols.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Technical:
- Strong experience in Quality system such as Deviations,
Auditing or Change Control
- Expertise in Standard Operating Procedures, Good
Manufacturing Practices, Food and Drug Administration, and other national and
international regulatory requirements related to quality testing
Leadership:
- Leadership skills with proven ability to lead, engage,
motivate, and develop the workforce
- Good interpersonal, investigative and implementation
skills
- Demonstrated influencing, relationship building, and effective
facilitation skills
- Interpersonal effectiveness, facilitation and
organizational experience
Other Requirements:
- Ability to execute against the strategic and
tactical objectives provided by senior leaders both within Quality and outside
of the function
- Overall understanding of Quality Assurance specifications
and process In-depth understanding of QC/Pharma
- Proficiency with MS Office products (specifically Word,
Outlook, Powerpoint and Excel)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Apply Now