Supervisor, Quality Assurance 3Rd Shift

Responsible for supervising all Quality Assurance (QA) aspects of compounding pharmaceuticals for compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the supervisor over the QA operations/staff, coordinating day to day functions. 

Responsibilities may include:

• Supervises Quality Assurance staff on assigned shift
• Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions
• Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
• Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results.
• Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining QA records associated with internal and external testing
• Responsible to maintain all testing equipment in compliance, calibration and certification
• Assists in developing policies and procedures related to QA
• Promptly communicates with Operations regarding complaints, product issues/variance
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforces applicable personnel policies and procedures
• Other duties as assigned

Qualifications:

• Legally authorized to work in the job posting country
• High school Diploma or GED from recognized institution or organization required
• Bachelor’s Degree in Life Science or other related field preferred
• 1 year of supervisory or management experience required
• 2 years’ experience in Quality Assurance / cGMP / FDA regulated industry

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.