Supervisor, QC Lab - Compliance

Our Supervisor, Quality Control Lab

• Compliance 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 supervising the QC compliance team that includes managing daily activities, performance, and coaching and developing staff. This position coordinates activities including review of laboratory data, assisting the Manager with OOS investigations, issuance of controlled documents, DEA controls, and continuous improvement projects and CAPA for the QC lab. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Supervisor, Quality Control Lab

• Compliance Does Each Day:

• Oversees individuals responsible for review of all laboratory data including Potency, pH, and Particulate Matter for accuracy and compliance to standards

• Assists Manager, Quality Control Lab

• Compliance with investigations of all OOS results and laboratory deviations

• Provides leadership and oversight for compliance with FDA and DEA regulations

• Assists with assuring that all the activities are in compliance with cGMPs and agreement with QuVa business initiatives

• Assists with writing investigations as needed and work with Manager, Quality Control Lab

• Compliance to resolve and close the investigations in a timely manner. Must employ sound scientific judgement for conclusions and provide effective corrective actions

• Drafts SOPs to enhance the efficiency of the laboratory

• Supervises staff to deliver timely and effective technical/compliance review and approval of lab data

• Provides quality oversight of Laboratory, through structured periodic compliance audits

• Writes SOPs and follows policy, procedure, and applicable government regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards and safety requirements

• Mentors and guides QC compliance team

Our Most Successful Supervisor, Quality Control Lab

• Compliance:

• Lead, plan, schedule, prioritize, and supervise staff and resources to meet project goals

• Make decisions and set priorities, schedule work for self and others (when needed), work with minimum direct supervision, and respond to emergency situations

• Interact with management, co-workers and subordinates in a calm, courteous and professional manner

• Observe and constructively train and correct laboratory and production staff as well as collaborate with management to resolve issues in a timely manner

• Communication: 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

• Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

• Effectively and productively engages with others and establishes trust, credibility, and confidence with others

• Customer Orientation: Listens to customers, ensures commitments are met, sets appropriate customer expectations

• Strong Microsoft Word and Excel skills

Minimum Requirements for this Role:

• BS. or M.S. degree in chemistry, biology or related field

• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry

• 3 years of supervisory or management experience

• Understanding of cGMPs and cGDPs; regulatory and safety requirements

• Proficient with a variety of analytical instrumentation, such as HPLC, GC, TLC, and Titrators

• 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:

• Experience in sterile manufacturing

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 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."