Quality Control Data Reviewer 1st Shift - Quva : Job Details

Our Quality Control Data Reviewer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. After training, responsibilities include performing review of QC testing data for conformance to methods, SOPs, cGMP and Good Documentation Practices. This role helps ensure medications meet the highest standards of safety, efficacy, and quality, delivering meaningful impact on healthcare across the US.

• Review analytical testing of finished sterile products and raw materials, following all written procedures and cGMP, and provide assurance of accurate documentation of analyses.
• Conduct and document laboratory investigations with support from the Manager.
• Verify appropriate documentation for DEA controlled sample handling.
• Document completion of review and approval of data in the appropriate laboratory systems.
• Report any issues to the Supervisor upon discovery.
• Partner with the Supervisor to understand expectations and execute them independently based on project prioritization.
• Collaborate with Supervisor or Manager to meet project milestones and provide data accordingly.
• Read and understand SOPs and follow policy, procedures, and applicable regulations (cGMP, DEA compliance, quality standards, safety).
• Provide timely review of analytical data.
• Provide input to SOPs to enhance laboratory efficiency.
• Stay up to date on SOPs, cGMP and cGDP requirements.
• Communicate any testing issues to a supervisor, manager, or cross-functional groups such as Metrology as needed.
• Recommend improvements to analytical test methods or documentation to Supervisors or Managers.

• Detail-oriented with strong verbal and written communication skills.
• Highly organized.
• Knowledgeable in Microsoft Word and Excel.
• Fulfills expectations, maintains effective relationships, and communicates clearly with the team.

• 18+ years of age.
• Able to successfully complete a drug and background check.
• B.S. degree or higher in Chemistry, Biology, or related field.
• 3+ years of laboratory experience in the pharmaceutical industry.
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation.
• Must be currently authorized to work in the United States on a full-time basis; sponsorship for work visas is not available.

• Experience with Waters H-class HPLC and Empower software.

• Full-time, 2nd shift, Monday through Friday from 6:00 am to 2:30 pm. On-site in Bloomsbury, NJ. Safety-sensitive position and may be subject to random drug testing in accordance with applicable laws.

• Base pay range: $74,766.00/yr - $102,817.00/yr.

• Set, full-time, consistent work schedule.
• Comprehensive health and wellness benefits (medical, dental, vision).
• 401(k) retirement program with company match.
• 17 paid days off plus 8 paid holidays per year.
• Opportunity for career advancement within a national, high-growth company.

Quva is an equal opportunity employer. All employment with Quva is at-will.