ESSENTIAL FUNCTIONS
• Ensures proper systems, equipment, materials, training, and other resources are in place to meet production demands.
• Responsible for precise compounding of products in accordance with master specifications.
• Ensures products are manufactured to specifications and in complete accordance with all cGMP, SOP, and master batch records.
• Ensures area/facility cleanliness, equipment cleanliness, and proper operation and functionality of all equipment, hardware, tanks, and tools within the compounding facility.
• Ensures adequate staffing and resources available on shift to meet production demands.
• Ensures all documentation is correct and addresses procedural /documentation errors expeditiously and effectively.
• Works closely with materials management and quality to addresses materials issues.
• Works with engineering and maintenance to minimize downtime, coordinate work scheduling, and ensure equipment is maintained in proper operating and validated conditions.
• Keeps employees informed of plant and department relevant activities/issues.
• Leads, trains, and develops employees in subordinate roles to effectively manage the department in accordance with company policies.
• Ensure proper operational supplies and consumables are on hand to meet production requirements.
• Complies with and enforces all hazardous material handling and safety requirements.
• Ensures investigations and corrective actions are completed in a timely manner.
• Fosters a culture of continuous improvement and sets goals and standards designed to challenge team members, increase capacity, and reduce errors.

EDUCATION/EXPERIENCE REQUIREMENTS
• B.S. Degree required (may substitute equal combination of education and experience)
• Must have good understanding of cGMP requirements.
• Must have a proven technical understanding of processes system operations, equipment and problem solving.

Qualifications
Computer/Software Skills
Requires proficiency in basic MS Word, Outlook, Excel
Requires proficiency in advanced MS PowerPoint, Project, Visio
Compliance Knowledge
Requires ability to deal appropriately with regulatory agencies
Requires general knowledge of cGMP, OSHA, DEA, USP and EP
Requires detailed knowledge of cGMP, OSHA, DEA, USP and EP
General Competencies
Requires flexibility and ability to multi-task
Requires strong written and verbal communication skills
Requires strong organizational and time management skills
Requires strong critical reasoning and decision making skills
Requires strong teamwork and facilitation skills
Requires ability to develop others, delegate and motivate
Written Communication
Requires ability to interpret / write general business documents
Requires ability to interpret / write technical documents
Requires ability to interpret / write complex business documents
Training Skills
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
Requires strong presentation development and delivery skills
Problem Solving
Requires ability to solve routine and complex problems
Level of Supervision
Does not require direct supervision
Impact of decisions
Impacts multiple departments
Requires uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment
Requires screening (full physical, antineoplastic medical surveillance)
Requires the ability to wear a respirator
Requires safety alertness due to work around hazardous equipment and conditions
Requires personnel monitoring due to handling of hazardous substances
Requires ability to wear specific PPE (full face respirator, clean room “bunny” suit)