Our Manager, Quality Assurance – Formulation plays a vital role within our organization. Once you complete our training, your responsibilities will include managing all Quality Assurance aspects of bulk formulation manufacturing of sterile pharmaceuticals within the facility. The primary function is to provide all quality oversight and management of the formulation operations, provide quality guidance to the teams that prepare batches, compound drug products, while meeting department quality, safety, delivery, and productivity objectives. The Formulation Quality Assurance Manager oversees the team that completes batch record documentation and manufacturing operations logs quality reviews and ensures people and processes comply with safety requirements, current Good Manufacturing Practices, company policies and procedures. This position establishes & maintains cooperative cross-functional relationships with peers in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives. 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.
What The Manager, Quality Assurance – Formulation Does Each Day
- Manages all Manufacturing Quality Assurance team members within the formulation department providing learning, development and coaching when appropriate
- Possess the ability to make quality assurance decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
- Responsible for timely and accurate 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
- Periodically reviews records to verify that quality standards for each drug product is met
- Maintains 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 for maintaining 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
- Hires, trains, and coaches employees
Our Most Successful Manager, Quality Assurance - Formulation
- Has strong technical writing and verbal/written communication skills, including presentation skills
- Develops action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
- Has successful time management skills in order to coordinate successful accomplishment of an approved action plan with timelines and milestone tasks
- Understands process flows, gap assessments and analysis of data to drive improvement
- Proficient with computerized tracking tools
- Has comprehensive knowledge of Adult learning techniques
Minimum Requirements For This Role
- Bachelor’s Degree in Life Science or other related field
- 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
- 3 years of supervisory or management experience
- Experience training personnel on aseptic techniques and appropriate gowning techniques
- Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
- Able to successfully complete a drug and background check
- 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
Benefits Of Working At QuVa
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 22 paid days off plus 8 paid holidays per year
- National, industry-leading high growth company with future career advancement opportunities
About QuVa
QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa’s integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-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 Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is “at will.”
