Quality Control Data Reviewer 1st Shift

QUVA • Bloomsbury, NJ

107d • $74,766 - $102,817

About The Position

Our Quality Control Data Reviewer plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include performing review of QC testing data for conformance to methods, SOPs, cGMP and Good Documentation Practices. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 2nd shift, working Monday through Friday from 6am to 2:30pm. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

Requirements

• 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 or more 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; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Experienced with Waters H-class HPLC and Empower software

Responsibilities

• Reviews analytical testing of finished sterile products, and raw materials, following all written procedures and cGMP, and providing assurance of accurate documentation of analyses
• Conducts and writes laboratory investigations, with support from the Manager
• Verifies appropriate documentation for DEA controlled sample handling
• Documents completion of review and approval of data in the appropriate laboratory systems
• Reports any issues to the Supervisor upon discovery
• Partners with their Supervisor to understand overall expectations and execute them independently based on the prioritization of projects
• Reads and understands SOPs and follow policy, procedure, and applicable government regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards and safety requirements
• Provides review of analytical data in a timely manner
• Provides input to SOPs to enhance the efficiency of the laboratory
• Keeps up to date on SOPs, cGMP, and current Good Documentation Practices (cGDP) requirements
• Communicates as needed any testing issues to either a supervisor or manager or to a cross-functional group such as Metrology
• Recommends to Supervisor or Manager improvements to analytical test methods or documentation

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Securities, Commodity Contracts, and Other Financial Investments and Related Activities
• Education Level: Bachelor's degree