Production Supervisor

Stokes Pharmacy•Mount Laurel Township, NJ

14d•Onsite

About The Position

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.

Requirements

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.
Prior supervisory experience mandatory.
Advanced skill in managing associate’s individual performance and development.
Innate ability to identify people skills and leverage them into immediate, long-term, and stretch goals while maintaining consistent performance and product quality.
Strong verbal, written, and oral communication skills.
Critical thinking skills not just escalating issues but offering potential solutions.
Able to aseptically gown and pass annual and periodic aseptic qualifications.
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.
Must have knowledge of 21 CFR Part 210 and 211 for cGMP operations.
Strong knowledge of cGMP, FDA, ICH and other regulatory guidelines.
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.
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.
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.

Nice To Haves

Aseptic processing preferred

Responsibilities

Ensure all procedures are adhered to and all processes are performed as intended following current Good Manufacturing Practices (cGMP’s).
Ensure you and the manufacturing team document and comply with Good Documentation Practices (GDocP’s).
Collaborate with quality partners and actively participate in quality investigations, deviations and corrective preventative actions (CAPAs).
Ensure the manufacturing personnel and floor adheres to Good Housekeeping Practices by maintaining a state of neat, clean, orderly and inspection readiness.
Conduct daily audits of the entire manufacturing floor and report weekly internal inspection findings to Quality Assurance.
Support internal/external audits.
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.
Diagnose and troubleshoot equipment and process issues.
Maintain a focus on quality product, potential process efficiencies, and optimization in support of continuous improvements.
Actively participate and support process validations and equipment qualifications.
Take a positive approach to lead and motivate staff.
Foster a high-performance, engaging work culture through coaching, mentoring and team building.
Manage individual and team performance, administer clear goals, expectations, and evaluations, and address associate relationship issues.
Look out for any unsafe conditions or unsafe behaviors to keep the manufacturing team and anyone in the manufacturing areas safe.
Immediately report and escalate any unsafe conditions, near misses or injuries to management for remediation.
Ensure all manufacturing associates, cross-functional associates and visitors in the manufacturing areas adhere to all safety precautions and wear the appropriate proper protective equipment (PPE).
Ensure all hazardous materials and waste are handled, processed, and disposed of correctly.
Actively participate and encourage others to participate in site EHS initiatives.
Ensure 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, have scheduled or as needed executed preventative maintenance, and are within current calibration (as applicable) prior to use.