Production Manager (NIGHTS)

Job Description

Job Description

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work Monday – Friday overnights, approximately 9PM – 6AM and would be eligible for a 10% shift premium.

I. Position Overview:

The position is responsible for the daily operations associated with sanitization, formulation, filling and packaging of products manufactured at the facility. Primary responsibility is to manage operations in accordance with manufacturing schedules, customer specifications and established quality standards to minimize disruptions and maximize throughput. Position is responsible for effectively managing the staffing, schedule adherence, and supervision of the operations. Position is focused on first-pass quality, managing deviations, minimizing re-inspections, reduction of scrap and overall OEE. Position is held accountable through metrics related to productivity, quality, safety and training compliance.

II. Specific Duties, Activities, and Responsibilities:

• Drive towards consistent execution across all shifts.
• Establish through visual management and continually enhance self-sustaining processes that drive associate involvement while maintaining compliance with all cGMP requirements and achieving business goals and objectives.
• Provide manufacturing representation during FDA audits.
• Support all validation and New Product Development (NPD) activities.
• Manage safety processes through personal modeling of appropriate behaviors and:

1. Safety awareness and training

2. Injury prevention and management

3. Safety policy accountability

• Leads and directs investigations and corrective actions for all production deviations and non-conformances.
• Leads and performs activities related to the creation, maintenance, and revisions of Standard Operating Procedures, Batch Records, and Manufacturing policies.
• Provide expectations, evaluation feedback, coaching assistance and career development support to direct reports.
• Ensure direct reports are properly cross-trained in all areas they may be required to work.
• Creation, maintenance and adherence to the departmental budget.
• Responsible for ensuring all production areas are in a state of good repair and in inspection readiness state.
• Troubleshooting equipment issues. Working in conjunction with maintenance personnel and supervision to ensure issues are addressed in a timely fashion.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

• Bachelor of Science degree or equivalent experience is required

Experience:

• Minimum five (5) years of progressively greater supervision and management responsibility
• Minimum one (1) year aseptic, pharma or food experience preferred

Knowledge/Skills Requirements:

• Excellent problem solving and analytical skills; ability to make sound judgements.
• Must be able to interact effectively with a variety of individuals and personalities within and between departments.
• A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
• Works well under pressure and able to prioritize workloads; ability to progress against frequently changing objectives/priorities.
• Foster teamwork to get results.
• Demonstrate a willingness to share skills and information with others; as well as collect and develop ideas from others.
• Review batch records for accuracy.
• Must be able to perform risk assessments in a timely manner and act accordingly.
• Should be familiar with GDP, cGMP and safe work practices.
• Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification.
• Be willing to take a position and assert influence to drive improvement.
• Actively seeking opportunities for improvement from a Continuous Improvement (CI) and Execution perspectives.
• Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

• Ability to stand for up to 8 hours per day
• Visual Acuity (20/30 corrected vision)
• May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others
• Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, stooping, kneeling, crouching, talking, bending, grasping, listening
• Occasional walking up inclines and uneven terrain, writing, carrying
• Occasional lifting and/or moving up to 30 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.