20 days old

Quality Assurance Associate - QA Data Review

Kelly Services
Oakdale, MN 55128
**Associate Scientist III - QA Data Review**

**M-F 8am-5pm**

**Oakdale, MN**


This is a non-laboratory position - office position. The ideal candidate is one who thrives working in a highly dynamic, team- oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical and medical device products. The Quality Assurance Associate Scientist III - Data Reviewer is responsible for review of laboratory technical records. Technical records can be documented in worksheets or electronically. Laboratory activities vary from routine, compendia type analyses to more complex client specific chromatographic methods, in support of testing pharmaceutical and medical device products. The QA Data Reviewer reports to the QA Group Leader. The ideal candidate is self-guided and highly motivated, demonstrating a strong sense of self-initiative and flexibility, a desire to collaborate with all departments and an interest in continuing to acquire new knowledge and skills. Preferred qualifications include either GMP laboratory or data review experience in wet chemistry techniques and spectrophotometric techniques, such as UV-VIS, liquid chromatography, gas chromatography, mass spectrometry including LC-MS, ICP-MS and GC-MS, Waters Empower Chromatography Data System, and other general laboratory techniques. Mass spectrometry experience is needed for this role.

**Job Responsibilities:**

+ Perform review of laboratory technical records while ensuring that client due dates are met. Provide support to other members of the QA Data Review Team.

+ Review and approve final analysis reports.

+ Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications e.g., ELN, LIMS, Waters Empower Chromatography System .

+ Assure all work performed is compliant with SOPs and GMP requirements.

+ Become familiar and regularly updated with quality and regulatory policies associated with the technical area.

+ Participate in quality, cGMP, safety, method and technique training appropriate for their area.

+ Other tasks as assigned by QA Group Leader


+ Keen attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment

+ Strong interpersonal skills

+ Strong verbal and written communication skills

+ Ability to excel in a fast-paced work environment

+ Ability to work independently, multi-task and be flexible with changing priorities

+ Bachelors Degree in Chemistry preferable

+ Five years minimum of laboratory experience, preferably in FDA regulated laboratory environment

+ Empower experience is preferred

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-11 Expires: 2020-12-12

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Quality Assurance Associate - QA Data Review

Kelly Services
Oakdale, MN 55128

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