14 days old

Senior QA Laboratory Analyst

Kelly Services
Windsor, CO 80551
**Senior Quality Control Analyst**

**Direct Hire**

**Monday-Friday (1st Shift)**


**Purpose and Scope**

The Senior QA Laboratory Specialist is responsible for providing quality oversight for Company Quality Control laboratories in accordance with policies, standards, procedures and CGMP. Functional responsibilities include ensuring accurate and timely review of documents for Quality Control including specifications, SOPs work instructions and qualification documentation. This position will provide compliance oversight for the QC laboratories, ensuring accurate and timely review of laboratory investigations, performing analysis on quality-indicating data, identifying any trends noted for QC data and functioning as the quality representative to provide support for laboratory activities associated with R&D and continuous improvement.

**Essential Duties & Responsibilities**

+ Support Analytical and Microbiological QC laboratory oversight activities for the Quality Operations group.

+ Work with laboratory management to ensure laboratory activities comply with regulatory requirements, including data governance and data integrity requirements.

+ Ensure procedures are adequate to review and confirm appropriateness of laboratories raw data.

+ Review and approve of laboratory deviations and OOS/OOT investigations and accompanying CAPAs.

+ Review and approve documentation associated with the laboratories, such as specifications, procedures, test methods, variances, change controls and qualification activities.

+ Provide oversight of QC laboratories to ensure compliance with internal company policies and procedures.

+ Ensure method qualifications, method transfers, and analyst training requirements meet company and regulatory requirements.

+ Manage the development, implementation and maintenance of Quality Systems and activities related to the laboratories.

+ Support audits of Quality Systems/Operations.

+ Represent department in internal and external cross-functional teams.

+ Serve as Quality representative and oversight for process improvement projects and R&D activities in the laboratories.

+ Perform other duties as assigned.

**Knowledge, Skills & Abilities**

+ Knowledge in cGMP, 21 CFR 210, 211, 820 and ISO 13485.

+ Independent, organized and able to lead others to meet deadlines.

+ Ability to work in an independent and self-directed manner.

+ Ability to clearly communicate (oral & written) and work well with employees at all levels.

+ Able to prepare written communications and communicate problems to management with clarity and accuracy.

+ Ability to write procedures and reports clearly and accurately.

+ Ability to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.

+ Ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.

+ Computer literacy in Microsoft Word, Access, Excel and other MS Office programs.

+ Recognized subject matter expert on quality assurance topics within a laboratory environment.

**Education** **& Experience**

+ Bachelors degree in scientific discipline required.

+ Ten or more years of experience in the pharmaceutical industry working in a QC Lab.

+ Strong understanding of Analytical Methods.

+ 6 plus years of experience as a bench chemist

+ HPLC, pharma and GMP Experience

**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
Posted: 2020-01-13 Expires: 2020-02-13

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Senior QA Laboratory Analyst

Kelly Services
Windsor, CO 80551

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