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26 days old

QC Supervisor / Manager - Pharmaceutical's - Oceanside CA

Kelly Services
Oceanside, CA 92054
**Quality Control (QC) Supervisor / Manager - Pharmaceutical / APIs, Oceanside, CA**



**Summary of Job:** The QC Supervisor/Manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 cGMP operations to ensure compliance with regulatory requirements and managing the quality control functional group. The Quality Control team is responsible for all analytical activities associated with the support of manufacturing activities, including raw material testing.



**Essential Duties and Responsibilities:**




+ Maintain and coordinate the operation of the Quality Control laboratory on a day to day basis.

+ Conduct and/or oversee the analytical methods validations.

+ Establish stability studies protocols and test method as needed.

+ Oversee the final product testing and release according to the corresponding approved SOPs.

+ Establishing raw material and final products specifications as necessary. Overseeing raw material and final products testing and release according to approved procedures.

+ Writing standard operating procedures, standard testing procedures and other related GMP documents including QC reports.

+ Oversee the training of the QC personnel.

+ Investigate deviations and out of specification results.

+ Take part in customer and/or suppliers audits as subject matter expert.

+ Ensure the Safety Guidelines set forth by the company is followed in QC lab.



**Job Requirements:**




+ Bachelor's degree (BS) in Chemistry with 3-5 years in a laboratory environment including experience with analytical equipment (e.g.: HPLC, UPLC, GC, MS, GC, KF, FTIR). * **UPLC Preferred**

+ Experience working in a regulated environment. **ICH Q7 preferred** .

+ Experience with analytical methods development and validation.

+ Experience with validation and method transfer. Method Development (UPLC / LCMS / MS)

+ Experience with equipment calibrations, maintenance and qualifications.

+ Proven ability to lead, coach, and motivate employees.

+ Clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of two years in a management position preferred.

+ Experience in project management is a plus.

+ Flexible schedule to accommodate workload. May require off-shift work hours as job demands.

+ Able to attend to details and act decisively.

+ Ability to manage changing priorities and meet deadlines consistently.

+ Must have excellent interpersonal, written, oral presentation, and verbal communication skills.

+ Must have excellent organizing and time-managing skills.

+ Proficient in Microsoft Word, PowerPoint and Excel.






**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
Posted: 2019-10-18 Expires: 2019-11-18

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QC Supervisor / Manager - Pharmaceutical's - Oceanside CA

Kelly Services
Oceanside, CA 92054

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