Process Supervisor - Manufacturing Quality Engineering

Nature and Scope

This position is responsible for managing the data analysis and technical writing functions associated with the commercial aseptic manufacturing of drug products. This responsibility is fulfilled by leading the resources that drive timely, accurate, and compliant completion of Events/CAPAs/Change Controls, Manufacturing APRs, and Media Fill Master Plan Preparation and Reporting. The position scope encompasses the following Operations departments: Manufacturing [Compounding, Equipment/ Component Preparation, Sterile Filling, Inspection and Packaging], Validation, Engineering, and Facilities. The supervisor will provide the necessary leadership to achieve product quality, cost control, cGMP compliance, safety, and the execution of production schedules to support customer service objectives. Additionally, the supervisor will provide daily oversight of their process to reinforce that department remains in compliance with all company SOPS, maintaining data integrity for all GMP processes and any department-specific requirements. Additional compliance must be met for all regulatory requirements - FDA, OSHA, OFCCP, EPA, etc.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Ensure compliance to quality systems and partner with Quality functions to determine direction for Manufacturing.

• Complete and oversee the completion of events, CAPAs, technical documentation revisions, change controls, and Manufacturing APRs. Deliver training to direct reports and Process Supervisors of Manufacturing to support their competency in these functions.

• Collect and oversee the collection of data to prepare supporting documentation for media fill execution.

• Assure special projects receive proper Manufacturing and Quality support to succeed.

• Work with manager and cross-functionally to establish key business initiatives and sponsor involvement, direction, and accountability to projects for improving department or plant performance.

• Train personnel on technical documents, including SOPs, job aides, batch records, or revisions to the like, to minimize human errors and support effective job performance.

• Drive the organization toward maximum efficiency and manufacturing operational excellence through leadership and a commitment to employee feedback.

• Bring together functional resources to meet product release timelines and organizational/quality objectives.

• Monitors safety and take positive steps to eliminate hazardous situations, notify necessary personnel for further corrective action.

• Escalate potential quality issues and observations to Quality and Manufacturing management for resolution.

• Compile and analyze information from multiple sources and consolidate it clearly, accurately, and appropriately into technical documentation.

• Develop and grow direct reports through performance and training plan management. Evaluate job performance and attendance as required. Investigate and resolve disciplinary issues up to and including suspensions and terminations.

• Develop and grow team through team building and by overseeing the interviewing/hiring processes as applicable.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• B.A. or B.S Degree required. Candidate with equivalent years of applicable experience will be considered.

• Minimum of 2-5 years' experience with sterile manufacturing and/or Quality Systems, required.

• Minimum of 3 years' of previous leadership experience in a GMP regulated industry, preferred.

• Superior technical writing, critical thinking, and problem-solving skills, required.

• Experience in TrackWise, Veeva Vault, and Microsoft Office, required.

• Strong oral, written, communication, presentation, and interpersonal skills. Capable of interfacing with multiple levels of people within the organization, including corporate management, third party customers, and plant personnel, required.

• Experience working in a cross-functional, matrix environment to drive projects to completion, required.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

• Experience in a pharmaceutical industry, preferred.

• Understanding of Six Sigma Basic Principles, preferred.

• Working knowledge of environmental monitoring and aseptic manufacturing, preferred.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

• Employee must be able to occasionally lift and/or move up to 15 pounds.

Expected Salary Range:

$89,100-$100,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.