Quality Control Data Reviewer 1st Shift

NJ - Bloomsbury Site
519 NJ-173
Bloomsbury, NJ 08804, USA

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, working Monday through Friday 6:00 AM - 2:30 PM. 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.

• 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
• This individual will work with the Supervisor or Manager to understand overall expectations and provide data to meet project milestones
• 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
• Provides updates to the QC Microbiologists about priority testing such as stability and validation
• 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

• Detail-oriented with strong verbal and written communications skills
• Highly organized
• Knowledgeable in Microsoft Word and Excel
• Fulfills expectations, establishes sustainable relationships with team members, maintains effective and meaningful communication channels

• 18+ years of age
• Able to successfully complete a drug and background check
• B.S. degree or higher in Biology, or related field. Relevant experience can be substituted on a case by case basis
• 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

• Experienced with microbiology testing such as sterility, endotoxin, growth promotion, and bioburden
• Experienced with Sample Manager

• 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
• The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions

Quva is a national, industry-leading provider of compounded injectable medicinesand software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva Bright Streampartners with health-systems to analyze large amounts of data and through AI and machine learning,develops software solutions that turns the data into insights that are used to better run their pharmacy operation.

Quva’s overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity…