- Runs operation to meet or exceed delivery performance objectives for product or projects
- Supervises staff in execution of daily work; assures operators comply with validated parameters and standard operating procedures, cGMP regulations and safety requirements; provides constructive operator feedback
- Counsels, trains, & develops technicians for efficient performance; creates an atmosphere of team effort & open communication
- 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
- Troubleshoots or resolves issues impeding daily/weekly deliverables; proactively demonstrates the ownership to achieve
- 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, GMP tasks) to on-time closure
- Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications
- 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
- High school Diploma or GED from recognized institution or organization required
- 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
- 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
- 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
- Bachelor's Degree in Life Science or another related field
- Computer Skills
- Training Software
- Microsoft Suite
- ERP software
- 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
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Supervisor, Manufacturing Operations - Bloomsbury, United States - QuVa Pharma
Description
Our Supervisor, Manufacturing Operations (Compounding) plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, you will be responsible for daily coordination and working schedules of people and equipment in Compounding Operations. 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.
This is a full-time role for our 2nd shift, working Monday through Friday from 10PM to 6:30AM. This is a set, consistent schedule based on site in our Bloomsbury location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.
What the Supervisor, Manufacturing Operations (Compounding) Does Each Day:
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."
