FLSA Status

Non-Exempt

Salary

Starting at $30/hour based on experience plus twice a year bonuses

Job Summary

This position requires an individual who has prior experience with and adapts well to a cGMP compliant pharmaceutical manufacturing environment. The Production Supervisor must be a proven leader that has administratively and effectively managed teams of technicians. The ideal candidate is a coach that identifies and continuously develops individual talent, actively targets areas for improvement, and continuously promotes a positive culture of inclusion and engagement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Quality Compliance:
  • As the production supervisor, it is vital that all procedures are adhered to, and all processes are performed as intended following current Good Manufacturing Practices (cGMP’s).
  • You must ensure you and the manufacturing team document and comply with Good Documentation Practices (GDocP’s).
  • As a subject matter expert and a leader of manufacturing, you are a process owner who collaborates with quality partners and is an active initiator and participant with quality investigations, deviations and corrective preventative actions (CAPAs).
  • You must ensure the manufacturing personnel and floor adheres to Good Housekeeping Practices by maintaining a state of neat, clean, orderly and inspection readiness.
  • Must have knowledge of 21 CFR Part 210 and 211 for cGMP operations
  • Strong knowledge of cGMP, FDA, ICH and other regulatory guidelines.
  • Conducts daily audits of the entire manufacturing floor and reports weekly internal inspection findings to Quality Assurance.
  • Supports internal/external audits.

• Manufacturing Floor:
  • Oversee the day-to-day manufacturing activities to include material requirements, setups, compounding, filling, tableting, packaging, and labeling.
  • Coordinate the daily workflow by assigning tasks to the manufacturing team, frequently touching base on processes and coordinating with cross-functional partners such as Quality Assurance to ensure production maintains compliance and scheduled deadlines are met.
  • Proactively anticipate the production schedule, assess human resource availability, and ensure the manufacturing team is provided with all the tools necessary to make them successful.
  • Ability to diagnose and troubleshoot equipment and process issues which means becoming a subject matter expert (SME) for manufacturing.
  • As the SME, there should always be a focus on maintaining a quality product, potential process efficiencies, and optimization in support of continuous improvements.
  • Actively participate and support process validations, equipment qualifications.

• Team Leadership and Development:
  • The ideal candidate must relentlessly take a positive approach to lead and motivate staff.
  • Foster a high-performance, engaging work culture through coaching, mentoring and team building.
  • In a timely manner, the Production Supervisor manages individual and team performance, administers clear goals, expectations, and evaluations, and addresses associate relationship issues.

• Associate and Site Safety:
  • Daily activities also include looking out for any unsafe conditions or unsafe behaviors to keep the manufacturing team and anyone in the manufacturing areas safe.
  • Any unsafe conditions, near misses or injuries should be immediately reported and escalated to management for remediation.
  • Must ensure all manufacturing associates, cross-functional associates and visitors in the manufacturing areas adhere to all safety precautions and do the appropriate proper protective equipment (PPE).
  • Ensures all hazardous materials and waste are handled, processed, and disposed of correctly.
  • Actively participate and encourage others to participate in site EHS initiatives.

• Manufacturing Equipment:
  • The Production Supervisor is directly responsible for ensuring all equipment, support equipment, spare parts, and associated tools are:
    • readily available for scheduled production
    • maintained in a good state of repair
    • cleaned appropriately according to procedures
    • scheduled or as needed executed preventative maintenance
    • are within current calibration (as applicable) prior to use.

Required Skills and Qualifications

Experience

• Minimum 3-5 years in pharmaceutical manufacturing, aseptic processing preferred with at least 2 years supervision experience in a GMP environment.
• A solid understanding of GMP guidelines and adherence to regulatory requirements.
• Proficiency with manufacturing batch / lot / materials software such as ERP, MES/EBR, LIMs, etc.
• Prior experience with using attendance and performance management systems such as ADP.

Skills

• Prior supervisory experience mandatory.
• Absolutely must have advanced skill in managing associate’s individual performance and development.
• Must have an innate ability to identify people skills and leverage them into immediate, long-term, and stretch goals while maintaining consistent performance and product quality.
• Must possess strong verbal, written, and oral communication skills.
• Must possess critical thinking skills not just escalating issues but offering potential solutions.
• Must be able to aseptically gown and pass annual and periodic aseptic qualifications.

Education

• Minimum education requirements include a science related bachelor’s degree or advanced equivalent work experience.

• Other Notable Requirements
  • Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas).
  • Must be able to work independently and with a team.
  • Ability to recognize priorities and actively make productive use of time to build operational efficiencies.
  • Must be agile, willing, and able to adapt to changing priorities.
  • Must exhibit punctuality and low absenteeism.
  • Able to sit and/or stand 8-10 hours or more per day as needed.
  • May need to lift to twenty-five (25) pounds on occasion.

Competencies

• People Development
• Communication Skills
• Organizational Skills
• Problem Solving/Analysis
• Results Driven
• Technical Capacity
• Detail Oriented

Supervisory Responsibility

This position manages associates in the Manufacturing Department and is responsible for the performance management and hiring of the employees within the department.

Work Environment

This job operates primarily in a controlled GMP manufacturing environment. This position requires the use of standard office equipment, and frequent standing and walking.

Language Skills

Must be able to read, write, speak, and understand English fluently and the ability to interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication, and the division of numbers including decimals and fractions when checking reports, forms, records, and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Able to sit and/or stand 8-10 hours or more per day as needed
• May need to lift to 25 pounds on occasion

Travel

Minimal travel may be required for this position.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.

AAP/EEO Statement

Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.