CenterWatch

1+ months

Quality Manager- Pharmaceuticals/Biotechnology, Torrance, CA

Kelly Services
Torrance, CA 90509
**Quality Manager - Pharmaceuticals/Biotechnology, Torrance, CA**



**Job Summary:**



This position will be responsible for working with applicable departments in the implementation, performance, and management of quality activities.



**Duties:**




+ Implement policy and procedures to maintain the regulatory compliance of the facilities.

+ Provide quality & regulatory technical guidance to Process Development, Laboratory Operations, and Software Departments.

+ Host vendor and regulatory agency audits, as applicable.

+ Perform supplier and internal audits of analytical laboratory, microbiology, clinical, etc. per the audit schedules.

+ Administrator and primary contact for the CAPA program. Maintain follow-up on audit issues until completion, while providing corrective action leadership.

+ Recognize the need for investigations due to deviations from written procedures, review investigations into non-conformance incidents/deviations, and recommend disposition of the affected product/component.

+ Facilitate and ensure timely completion of deviation/investigation reports.

+ Prepare trend reports related to in-process monitoring, deviation reports, investigation reports and CAPAs. Follow-up with functional department for timely completion of corrective and preventive actions recommended.

+ Manage SOP and regulated documentation systems.

+ Support the preparation and or review of new, revised SOPs or test methods.

+ Maintain Change Control and OOS systems.

+ Interact with management personnel from the various departments to monitor QA programs and provide feedback for improved quality.

+ Develop and provide quality metrics and trending evaluation to Management.

+ Perform quality and regulatory related training.

+ Represent quality activities to current or potential customers.

+ Manage, coach and develop team members, as assigned.

+ Perform other duties as assigned.



**Qualifications:**




+ Previous pharmaceutical industry experience, specifically in a GMP or GLP environment, in Quality Assurance or regulatory compliance. (3+ years)

+ Must have at least a BS in Life Science field (preferable Chemistry) plus 3+ years of industry experience

+ Minimum 2 years supervisory experience.

+ Experience with FDA and ISO audits

+ Strong organizational and leadership skills.

+ Experience with Quality Systems

+ Previous supervisory experience.

+ Experience with regulated software design, including 21 CFR Part 11 compliance.

+ Previous pharmaceutical industry experience in validation documentation preparation and execution.

+ Familiarity with ICH, ISO and international regulations.

+ Project management skills.

+ Travel up to 5% may be required.



**For Immediate Consideration, Apply Today! Questions?** **Call Grace at 714-971-0721 or Email at grace.piper@kellyscientific.com**








**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

Categories

Posted: 2019-08-09 Expires: 2019-11-18

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Quality Manager- Pharmaceuticals/Biotechnology, Torrance, CA

Kelly Services
Torrance, CA 90509

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast