Manager, Quality - Shipping Center

Our Supervisor, Manufacturing Operations (PC) 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 overseeing all quality related activities at QuVa’s Shipping Center. The Shipping Center is the entry point for receiving finished products from QuVa’s manufacturing sites as well as the hub for shipment to QuVa’s west coast customer base. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What The Manager, Quality – Shipping Center Does Each Day

• Supervises all Quality staff
• Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
• Oversees failure and discrepancy investigations and documenting investigations on incoming supply process deviations
• Provides an established technical expertise for current processes and oversees training of personnel on new processes
• Responsible for timely and accurate release of incoming product to ensure the delivery schedule is not impacted
• Reviews and approves of shipping documentation for commercial products
• Oversees the incoming and outgoing lot disposition of all sterile material as well as CSP batches
• Reviews quality documents to verify that quality standards have been met (COA, COC)
• Maintains compliance with DEA, FDA, 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining incoming quality records associated with release of CSP
• Assists in developing policies and procedures
• Assists in maintaining compliant controlled substance documentation specifically associated with each CSP lot
• Enforces applicable personnel policies and procedures
  
  

Our Most Successful Manager, Quality – Shipping Center

• Has a sense of urgency, accountability and resourcefulness
• Is a self-starter, independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
  
  

Minimum Requirements For This Role

• Bachelor’s degree in Life Science or other related field
• 5 years prior experience in Quality Assurance / cGMP / FDA regulated industry with 3 years of management experience
• Well versed in compliance & quality requirements of the pharmaceutical industry and cGMP’s
• Efficiency with MS Office suite
• 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
  
  

Any Of The Following Will Give You An Edge

• ERP experience
  
  

Benefits Of Working At QuVa

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 22 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities
  
  

About QuVa

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

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.”