Are you a QA Data Reviewer who is looking to 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.

• 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 forms.

• Overview of Stability Program, Analytical instruments data review (LabX, FTIR, UV, KF, etc.),
• Analytical method validation report reviews, specification review, and sound knowledge of the USP and monographs and co-relating with the specs/analytical method validations.
• Knowledge of current Good Manufacturing Practices, United States Pharmacopeia, Current Federal Register (CFR), and other applicable FDA regulations or guidelines.
• Ability to write, read, and apply technical scientific writing, procedures, and quality policies.
• Ability to work independently in an efficient and detail-oriented manner.
• Ability to work independently, as well as in a group environment.
• Ability to apply deductive reasoning and analytical thought to understand complicated issues.
• Ability to receive instructions and follow work rules and company policies.
• Ability to follow safety and security practices.
• Ability to maintain confidentiality of certain information.
• Ability to meet attendance standards.

Additional Information:

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• While performing the duties of this job, the employee is regularly needed to sit, stand, walk, talk, and hear.
• The employee needed to use their hands to finger, handle, or feel.
• Specific vision abilities needed by this job include close vision for written work and PC use.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.