Description

Position Overview:

Responsible for managing all Quality Assurance aspects of compounding sterile 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 all Manufacturing QA staff providing learning and development where appropriate
• Ability to make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
• Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.
• Provides review/approval of Deviations / Investigations, CAPAs, Change Controls
• Generates procedures related to Manufacturing QA functions / activities
• Designs and maintains the environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
• Trains personnel on appropriate aseptic techniques and gowning techniques
• 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
• Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
• 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/variances
• Enforces applicable personnel policies and procedures

Qualifications:

• Legally authorized to work in the job posting country
• Bachelors Degree in Life Science or other related field, or equivalent experience
• Minimum 5 years prior experience in Quality Assurance / cGMP / FDA regulated industry
• Minimum 1 year of supervisory or management experience required
• Experience training personnel on aseptic techniques and appropriate gowning techniques
• Technical writing and communication
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and cGMPs and have demonstrated strength in problem solving and resolution
• Strong interpersonal skills

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.