Supervisor, Manufacturing Operations (Cleanroom Support) 2nd Shift

Our Supervisor, Manufacturing Operations (Cleanroom Support) plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. The Supervisor, Manufacturing Operations (Cleanroom Support) is responsible for daily coordination and activities required for the seamless support of Formulations and Compounding Operations. This person will supervise Support Technicians that prepare batches while meeting department quality, safety, delivery, and productivity objectives. In addition, responsibilities include Confirming completeness and accuracy of batch record documentation and manufacturing operations logs; ensuring people and processes comply with safety requirements, current Good Manufacturing Practices, company policies and procedures; modifying department standard operating procedures, investigates variances, and executes change controls to support safety, quality, and productivity objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives.

In partnership with the site leaders sponsors a safety, quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. 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 Supervisor, Manufacturing Operations (Cleanroom Support) Does Each Day:

Leads in the scheduling of personnel and assignment of resources to meet or exceed performance objectives

Supervises staff in execution of daily work; assures technicians comply with validated parameters and standard operating procedures, cGMP regulations and safety requirements; provides constructive feedback

Counsels, trains, & develops technicians for efficient performance; creates an atmosphere of team effort & open communication. Sets goals for employees and monitors progression toward success

Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to absences, unplanned maintenance or events requiring investigation

Provides support level resources to Sterile Operations as needed including cleaning, material and product transfer, staging of consumables, and/or replenishment of gowning components

Leads in development & maintenance of a safe manufacturing environment. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions

Completes in-process checks & verifications in alignment with Standard Operating Procedures

Reviews documentation such as batch records and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices

Develops technician training programs & assures operator training is conducted

Initiates documentation of violations and disciplinary action with operators as required

Reviews operational performance and drives improvement opportunities

Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes

Drives Quality Management System assignments (CAPA, Deviation, Change Control) to on-time closure

Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications

Our Most Successful Supervisor, Manufacturing Operations (Cleanroom Support):

Organizes and schedules other people and their tasks; defines performance goals, measuring performance against the goals

Leads, coaches and mentors team members; provides feedback of personal / team performance and documents such

Possesses working knowledge of safety standards and applies such to continuously improve the safety culture and metrics

Has working knowledge of cGMPs and regulatory requirements as well as all applicable SOPs

Meets productivity standards; Completes work in timely manner; Strives to increase productivity

Follows policies and procedures; completes administrative tasks correctly and on time

Prioritizes and plans work activities; Sets goals and objectives; Organizes or schedules other people and their tasks

Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments

Minimum Requirements for this Role:

High school Diploma or GED from recognized institution or organization

2-3 years prior experience in cGMP / FDA regulated industry

1 year of supervisory or management experience required

Successful completion of certified in-house qualification programs

Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution

Excellent Computer Skills

Experience with Training Software, ERP software, and Microsoft 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:

Bachelor’s Degree in Life Science or other related field

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

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.”