Team Quality Control Rep - BioTech position available

rlaughlin rlaughlin at peoplepc.com
Mon Oct 1 16:21:16 EST 2001


SWAT Team Quality Control Rep - BioTech position available 
This Leading Biotech and Pharmaceuticals Company has a very competitive compensation package and will pay for relocation!

Location: Indianapolis, IN

Type: DIRECT

Duration: Direct

Pay Rate: D.O.E.

 

Description:

QC departments touch all phases of our product pipeline including development, intermediate scale-up, large scale manufacturing, parenteral and dry product packaging and purchased raw materials.

 

The QC Rep ensures the finest quality of our finished products from their inception to the pharmacy shelf. The QC Rep provides assistance and guidance in investigations, change proposals, procedure and manufacturing instruction revisions and validations.

 

Additionally they coordinate the analytical testing of raw materials and manufactured lots and are responsible for approval of final material.

 

The QC Rep will assist with periodic self-inspections of the manufacturing area to assure GMP compliance and in preparation for inspections by various regulatory agencies. 

 

 

Job Responsibilities: 

* Provide leadership in establishing and maintaining Quality Systems. 

* Ensure appropriate execution of the Quality Systems to sustain a state of GMP compliance. 

* Approve products. 

* Review documentation and investigations. 

* Interpret and apply regulations, policies and guidelines. 

* Provide leadership for inspection, provide leadership for inspection readiness activities and ensure that the site is in constant state of inspection readiness.

 

 

Requirements:

Candidates for this position will have a BS/MS in Chemistry, Biochemistry, Microbiology, Pharmacology, Engineering or a related science. QA/QC experience is preferred. Prior experience in the pharmaceutical industry is desired but not mandatory.

 

Additional requirements include knowledge of cGMP and FDA regulations, strong communication skills, being a strong team player, good scientific judgement, ability to work independently, strong interpersonal skills, basic computer skills and an understanding of statistics.

 

MUST HAVE HANDS-ON INDUSTRY EXPERIENCE.

 

 

 

Contact:

To apply submit resume to:

Rick Laughlin

Direct Placement Recruiter

rlaughlin at volt.com

317-585-8788

In subject line please state job title.

 

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