21 days old

Analytical Data Auditor R&D

Kelly Services
St Petersburg, FL 33747
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an **Analytical Data Auditor R&D** at a prestigious Fortune 500 company working in **St. Petersburg, FL.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the Submit Resume button included within.

**Job Title: Analytical Data Auditor R&D**

**Pay: $33 per hour**

Department Overview:

The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, and in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of products and materials. The department provides analytical services to manufacturing, process development, validation, and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also supports CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburgs Quality departmental policies.

Basic Function:

Independently review and audit analytical data including notebooks, chromatographic data, validation protocols and reports and other analytical data protocols and reports. Document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies.

Specific Activities, and Responsibilities:

Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.

Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.

Approve analytical documents as the reviewer against applicable specifications/procedures.

Perform data certification in the electronic LIMS system if applicable.

Actively participate in corrective actions and continuous improvements.

Assist in complying with any other company and /or departmental objectives as directed by AR&D management.

Deliver on commitments to meet customer expectations.

All other duties as assigned.

Knowledge Requirements:

Education or Equivalent:

Requires a minimum of: MS in scientific field with 3 plus years, or BS in scientific filed with 5years or AS in scientific filed with 10 years in the analytical lab

Analytical laboratory / Pharmaceutical and or GMP experience preferred

Knowledge/Skills Requirements:

Prior quality assurance experience with CMC review is preferred.

Working knowledge of cGMPs regulations.

Certified Quality Auditor is a plus.

Must possess good interpersonal skills.

Ability to effectively communicate with co-workers.

Good organizational skills required.

Excellent oral and written communication skills.

Proficient in Microsoft Office. Good word processing skills.

Motivated, self-started, team player.

Physical/Mental Requirements:

Ability to identify problems.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Ability to work effectively under pressure to meet deadlines.

Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.

Be accessible to manufacturing, laboratory and office staff.

Be able to use required office equipment.

Vision requirements include reading of English documents and distinguish color.

Ability to work extended hours or off-hours as required.

Business Environment:

Stationed in either office or laboratory environment with moderate noise level

Required to wear proper PPEs when auditing equipment and log books

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** at **.**

**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**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: 2020-11-04 Expires: 2020-12-05

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Analytical Data Auditor R&D

Kelly Services
St Petersburg, FL 33747

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