This expertise level position is responsible for leading and completing Prolacta’s manufacturing processes without assistant while strictly adhering to current Good Manufacturing Practices (cGMP’s), Environmental Health & Safety guidelines, and other regulations that apply. The incumbent is responsible to lead the completion of daily job assignments in support of production activities. These activities include but not limit to manufacturing of bulk human milk concentrate, addition of mineral, pasteurization and filling, labeling printing and packaging operation, and equipment cleaning. This position requires teaching and assisting other entry/intermediate level technicians.
Primary Duties and Responsibilities
- Provides daily supervision and critical decision making on the floor to production personnel in the use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
- Accomplishes manufacturing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Manage shift headcount and capacity model to support current and future production needs, provide input and justifications to management on human capital plan.
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Maintains work flow by monitoring steps of the process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; implementing cost reductions; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points; initiating and fostering a spirit of cooperation and continuous improvement within and between departments.
- Owner of area SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
- Works collaboratively with cross functional teams to ensure flow of product, sharing of best practices and lean behaviors.
- Responsible for final review of completed manufacturing batch records and all documentation per compliance standards and establish timelines.
- Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to operation management.
- Ensures operation of equipment by calling for repairs; evaluating new equipment and techniques.
Job Requirements and Qualifications
- Degree in engineering, operation management, related life science, and 3-5 years of experience in production/warehouse supervision OR 10+ years of production/warehouse supervisor experience in a health care manufacturing environment involving process like thawing, jacketed tank mixing, temperature control, separation, filtration, sterile filling, labeling and packaging, handling biologics/human tissue donations, sampling, and product shipping.
- Previous experience in a pharmaceutical or highly regulated bioscience health care environment is preferred
- Knowledge of food, dairy, or infant formula cGMP is a plus
Other Knowledge, Skills and Abilities
· Some experience in managing budget
· Ability to work without supervision
· Effectively interview and select candidates
· Handle conflict management and bring resolution
· Effective relationship building skills
· Ability to produce and present clear, concise and professionally written communications and presentations
· Performance coaching and directing of others
· Positive attitude and motivation
· Ability to operate in a complex matrix environment
· Strong PC skills, MS Outlook, Word, etc.
· Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
· Strong Critical thinking and decision making skills
· Strong business ethics
· Scorecard management
· For manufacturing Lean and Six Sigma qualified
Work Environment (Location, travel, shift, on-call, etc.)
City of Industry