QC Auditor I

Job Title: QC Auditor I

Location : Iron Station, NC

Hours / Schedule : 8 AM- 5 PM, M-F

Type: Contract To Hire


***Empower experience highly preferred, 80% of position is reviewing Empower data. No fresh outs, needs at least 1 year of lab experience, preferably GMP ***



Requirements

• BS or BA in Chemistry or related science

• One year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc.)

• Prior experience (one year preferred) or ability to learn, FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.) as it pertains to a QC Laboratory

• Basic understanding of general chemistry principles

• Ability to read and interpret technical documentation, such as Monographs, GTMs, and USP/BP Test Methods, Protocols, and FDA Guidance

• Consistently audits basic electronic chromatography results analyses (i.e. active assays, IDs, isocratic analyses, etc.) for accuracy, completeness, compliance to GDPs and cGMPs and with no omissions or errors

• Equipment and Applications: USP and Empower

Responsibilities
The purpose of this position is to review QA/QC documentation, to assess data compliance/validity with regulatory guidelines in the Quality Control Department and ensure that all the work is performed and documented accurately, timely and in compliance with internal procedures and regulatory agencies.

• Provide technical support for the release of raw materials, finished products, and stability data.

• Ensure all recorded data is accurate, legible, complete, and documented in such a manner as to be understood by a 3rd party.

• Review all recorded QC data and assess it for compliance to applicable test methods, GDPs, and adherence to internal SOPs.

• Track and assist in resolution and close out of open and outstanding deviations, invalidations, out of trend reports, and out of specification investigations.

• Track and complete Training Guidelines & Training Effectiveness Tools for Auditor I.

• Other duties as assigned by management

Work Environment and Physical Demands (List required PPE’s)

• Safety Glasses

• Laboratory Coat

• Appropriate shoes and clothing

• This position requires minimal physical requirements. The incumbent is however, required to have manual dexterity and will be required to sit for hours using a computer.

• Ability to occasionally lift 50 pounds

Benefits


System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


#M3


Ref: #558-Scientific