Position Overview:

Performs release activities related to finished good products to ensure compliance with applicable SOPs and regulatory requirements are adhered to prior to release of product to market for commercial distribution.

Responsibilities may include:

• Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Performs second person review as part of release activities for completed Batch Records to ensure compliance to Regulatory and QuVa SOPs, product quality, and safety standards are met
• Promptly communicates with Operations and Manufacturing Quality Assurance regarding batch record discrepancies, product issues/variances
• Escalates procedural deviations or discrepancies that have product impact to the Quality Investigations Team for review
• Reviews Variances associated with batch records for impact to the product disposition
• Reviews QC testing results, and EMPM monitoring data, are within specifications
• Reviews QC testing results entered into Management System and confirms results that are generated on the product Certificate of Analysis (COA)
• Supports department Supervision in prioritization of day-to-day responsibilities
• Demonstrates high level of discretion and timely identification of events that may have an impact to product disposition/safety
• Works with other departments on Process Improvements and Corrective Actions
• Other duties as designated by Supervision

Qualifications:

• Legally authorized to work in the job posting country
• High School Degree or equivalent
• 3-4 years in a Quality Organization supporting cGMP Batch Record Review and Release Activities
• 4+ years of working experience in the batch release/lot disposition department in the pharmaceutical industry supporting release of raw materials and finished good products
• Previous experience training individuals
• Preferably, 1-2yrs in a QuVa Lot Disposition Specialist role reviewing batch records

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.