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26 days old

Compliance Data Reviewer - Direct Hire

Kelly Services
Salisbury, MD 21801
Kelly is pleased to offer a ****DIRECT HIRE**** **_Compliance Data Reviewer_** position with a large pharmaceutical company in Salisbury, MD!


+ This is a full-time, direct-hire position

+ First shift hours: Monday - Friday, 8am-5pm

+ Competitive Salary!

+ There is an excellent benefits package that includes but is not limited to Health, Vision, Dental, and 401K


**Position Summary:**

The Compliance Data Reviewer promotes an effective pharmaceutical quality system that aligns with the organizations quality concepts including GMP regulations and quality risk management elements that are implemented through the different stages of the product life cycle. The incumbent maintains all elements of data review ensuring compliance with current GMP regulations, Corporate and HR Policies, FDA, and any other regulatory requirements. This incumbent proactively prevents compliance gaps and leads process improvement efforts for data review/data integrity.


**Job Responsibilities:**


+ Performs thorough review of all raw data, electronic data, and documentation, including, but not limited to content, results, data accuracy, data integrity, and compliance to applicable SOPs, test method, specifications, and/or protocols.

+ Reviews method validation, method verification, and method transfer protocols and reports, as required

+ Recognizes the need for investigations due to out-of-speciation (OOS) results, out-of-trend (OOT) results, atypical results, and deviations from written procedures

+ Review analytical procedures, test methods, and reports, as required and ensure compliance to regulatory and compendia requirements

+ Provide support for investigations, as required

+ Conduct audit trail review of electronic laboratory systems, as required

+ Initiate SOP updates and improvements, as appropriate

+ Support internal and external audits, as required


**Requirements:**


+ BS Degree in Chemistry (preferred), or associated scientific field

+ A minimum of two (2) years of laboratory experience, preferably in the pharmaceutical industry

+ Experience evaluating analytical data, GMP documentation, and data integrity

+ Familiar with analytical testing methods and validation including laboratory instrumentation

+ Knowledge of pharmacopeia and compendia requirements

+ Strong critical thinking and problem solving skills

+ Familiar with laboratory computerized systems such as Empower, CDS, UV Winlab, etc.

+ Familiar with analytical testing methods and validation including laboratory instrumentation

+ Experience and knowledge in 21 CFR data integrity requirements


For immediate consideration, please email your resume to jenp440@kellyservices.com


\#P1


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


Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.


**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 (plus, did we mention we provide a ton of benefits ?). 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: 2022-07-20 Expires: 2022-08-20

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Compliance Data Reviewer - Direct Hire

Kelly Services
Salisbury, MD 21801

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