QA Data Reviewer

at Acara Solutions in Decatur, Illinois, United States

Job Description

Description

Are you a QA Data Reviewer who islookingto join one of the top companies within the Pharmaceutical Industry?
Are you looking to further your career and grow?
Do you have experience in handling Agilent and Thermo HPLC and GC's?
If you answered yes to those three questions, then apply today!
Acara Solutions is seeking highly qualified candidates to work Onsite with our client in Decatur, IL. Interested?
Here's what you'd do:
Ensure all source data, summary reports, and documentation from the laboratory are of the highest quality, ensuring data accuracy and integrity.
Reviews all analytical data for accuracy, conformance to procedures and specifications, and proper documentation by client SOPs and cGMPs.
Also, review raw data, for use of appropriate analytical instrumentation use, accuracy of calculations, and conformance to all referenced analytical procedures and review the interpretation of the data for alignment with method validation reports and scientific legitimacy.
Review all electronic data audit trails in detail to ensure data integrity is not compromised in any way and ensure all signatures, electronic or written are intact before the release of laboratory data.
Responsible for discussing data interpretation and questions with individual analysts and elevating, if necessary, to determine data disposition.
Responsible for ensuring the integrity of all data and documentation reported from the Quality Control Laboratory.
Review the raw testing data via the chromatography data acquisition system i.e. Chromeleon.
Review various laboratory instruments' raw data and their audit trials such as UV, FTIR, KF, TOC analyzers, Headspace analyzers, and Lab-X software for management of the off-line instrument data.
Review all source data and associated documentation for accuracy and cGMP conformance.
Review the applicable specifications for the raw material, finished product, and stability studies.
Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
Ensures Investigations are assigned to data or documentation, as appropriate before data verification is signed off.
Responsible for verifying all laboratory testing was conducted by SOP's as well as cGMP's and GLP's.
Review of Laboratory notebooks for completeness, and archival, as appropriate. Interacts closely with Quality Management and all team members to identify and aid in implementing data security, integrity, or efficiency improvements.
Understand testing and procedures within Quality testing.
Performs work by general and specific safety precautions.
Interacts with departments such as Production, QA, RA, R&D, and Validation.
Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance.
Assist in the investigation and review of deviation reports and OOS reports to ensure complete compliant source data.
Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.
Demonstrate a consistent high-level integrity, professional discipline, and dedication to quality compliance and improvement.
Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension.
Communicate regularly and effectively with all levels of the organization.
Here's what you'll get:
Pay rate: $80k/year
Hours: 40 hours/week
Length: Direct Hire
Sound like a good fit?
APPLY TODAY
About Acara Solutions
Acara is a premier provider of recruiting and workforce solutions we help companies compete for talent. With a legacy of needs in various industries worldwide, we partner with clients, listen to them, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

Job Requirements

Required Skills / Qualifications:
Bachelor's Degree in Chemistry or Biochemistry or Pharmacy.
Minimum of 5 years experience in handling Agilent and Thermo HPLC and GC's.
Minimum of 5 years experience in the Chromeleon (Agilent and Thermo HPLC/GC's), OOS handling in the laboratory, Laboratory personnel qualification
Minimum of 5 years experience in an industrial laboratory related to cGMP pharmaceutical manufacturing, specializing in sterile dosage... For full info follow application link.

Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.