211 Production Manager

Description: JOB SUMMARY: The Production Manager will oversee 211 manufacturing employees to ensure efficiency and quality in production operations in accordance to FDA and company guidelines. SUPERVISORY RESPONSIBILITIES: 1. Maintain fully trained manufacturing staff; hires and trains manufacturing personnel. 2. Organizes, directs and oversees the schedules and work of manufacturing employees. 3. Provides constructive and timely performance evaluations. 4. Provide opportunities for on-the-job training and SOP review as necessary. 5. Handles discipline and termination of employees in accordance with company policy. DUTIES/RESPONSIBILIITIES: 1. Collaborates with other managers and supervisors to coordinate activities in and among departments. 2. Optimize resource management by anticipating and ordering all inactive material and packaging components from the warehouse in a timely manner. 3. Create production batch records for all items produced in the manufacturing suite. 4. Ensure all contracts with outside vendors are current and in accordance with company standards. 5. Schedules all PM (preventative maintenance) and scale calibrations. 6. Regularly inspects and evaluates products for quality and defects. 7. Identifies and corrects problems and inefficiencies in process, materials, equipment, or skills. 8. Ensures legal compliance with federal, state, local, FDA, cGMPs and related regulations, guidelines, and best practices. 9. Ensure compliance to ensure a safe work environment. 10. Investigate, compose, and submit deviation and investigation reports in a timely and accurate manner. 11. Write and execute validation and rework protocols. 12. Write and execute equipment qualifications. 13. Performs other duties as assigned. Requirements: REQUIRED SKILLS/ABILITIES: 1. Excellent organizational skills and attention to detail. 2. Excellent time management skills with a proven ability to meet deadlines. 3. Strong verbal and written communication skills and the ability to work with all levels of management and vendors. 4. Strong analytical and problem-solving skills including the ability to read and understand instructions and materials in English; add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. 5. Strong supervisory and leadership skills 6. Ability to function well in a high-paced and at times stressful environment. 7. Thorough understanding of FDA, cGMP compliance regulations. 8. Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, or other related software. 9. Thorough understanding of scheduling and procurement of all inactive materials and packaging components used in manufacturing. 10. Fluency in reading, writing and verbal communications in English. EDUCATION AND EXPERIENCE: 1. Associates degree in related field, or equivalent industry work experience required. Bachelors’ degree in Management, Engineering, Business or related field preferred. 2. 3-5 years of supervisory experience, preferably in a pharmaceutical production facility. PHYSICAL REQUIREMENTS: 1. Prolonged periods of standing and walking through the manufacturing suite. 2. Prolonged periods of sitting at a desk working on computers. 3. Must be able to lift up to 55 pounds 4. Visual acuity to inspect products, including small label print, and machinery. 5. Ability to occasionally climb stairs.