Aseptic Manufacturing Supervisor

2 weeks ago

Woodstock, Illinois, United States Woodstock Sterile Solutions Full time
Job Overview

Woodstock Sterile Solutions is committed to enhancing global healthcare by delivering top-notch solutions for sterile development and commercial requirements. As a dynamic organization with a promising future, we seek dedicated and skilled professionals to join our workforce. We provide a comprehensive benefits package along with a generous Paid Time Off policy. This role is scheduled for Sunday to Tuesday and every other Saturday, from 6 PM to 6 AM. A 15% shift premium for overnight shifts and an $80 per pay period shift differential for 12-hour shifts are included.

I. Role Summary:

The primary responsibility of this position is to ensure that production activities align with established production targets. This role involves providing leadership and guidance to production staff and ensuring that new employees receive adequate training. Maintaining a safe working environment and adhering to cGMP regulations are critical aspects of this role. Accurate record-keeping and documentation are also essential.

II. Key Responsibilities:

Personnel Management

  • Encourage a culture of transparent communication, teamwork, and employee development.
  • Oversee employee attendance, including daily monitoring of timekeeping systems and managing PTO balances.
  • Conduct performance evaluations, including semi-annual and annual reviews.
  • Address and manage inappropriate behaviors, conflicts with company policies, and cGMP compliance, administering disciplinary actions when necessary.
  • Enforce all site policies and procedures uniformly, holding all staff to the same performance and conduct standards.
  • Follow established protocols for managing temporary workforce through third-party staffing agencies.

Production Oversight

  • Own and execute the production schedule, including preparation of rooms and equipment as necessary.
  • Handle pre-production tasks such as staffing, reviewing production schedules, batch records, and relevant SOPs to identify validation and production requirements; facilitate room cleaning and approval processes, and ensure correct components are documented in batch records.
  • Monitor ongoing responsibilities, including formulation, start-up, in-process quality testing, and tracking production operations.
  • Ensure production personnel within assigned areas maintain quality and efficiency while processing orders safely and in compliance with cGMP.
  • Participate in daily shift meetings at the beginning and end of each shift.
  • Sign off on batch records and ensure accuracy in documentation.
  • Ensure compliance with SOPs and batch records through routine quality checks, line clearances, and inspections.
  • Interact significantly with direct reports managing production lines, ensuring they are cross-trained for various tasks.
  • Troubleshoot equipment issues in collaboration with maintenance personnel.
  • Work closely with support teams to address quality or material concerns.
  • Assist with validations and R&D runs.
  • Conduct monthly safety audits to promote employee safety.
  • Evaluate current processes and provide cost-saving opportunities to the Operations Manager.
  • Deliver consistent leadership to achieve team performance as measured by site and business KPIs.
  • Collaborate with Warehouse, Planning, Operational Excellence, New Product Development, and Quality teams to resolve discrepancies and issues.

Compliance and cGMP Adherence

  • Ensure strict compliance with batch records and relevant SOPs, reporting documentation issues and material delays to the Operations Manager.
  • Complete assigned deviations within specified timeframes.
  • Maintain current SOPs and implement cGMP practices on the production floor.
  • Address customer complaints related to your work area and shift.
  • Support the effectiveness of Quality System components relevant to this position.
  • Perform additional duties as assigned.

III. Position Qualifications:

Education:

  • Associate's Degree required, preferably in Chemistry, Pharmacy, or Engineering OR
  • 5 years of experience in manufacturing or packaging operations, ideally in a pharmaceutical or regulated environment.

Experience:

  • Minimum of 3 years of supervisory or leadership experience in a similar environment.
  • Experience in a team-oriented cGMP environment preferred.
  • Background in a GMP-controlled setting is essential.
  • Experience in the pharmaceutical industry is advantageous.

Knowledge and Skills:

  • Intermediate mathematical skills.
  • Strong mechanical aptitude and problem-solving abilities.
  • Excellent documentation and communication skills.
  • Proficiency in business computer applications (e.g., MS Office).
  • Ability to work independently and meet deadlines under pressure.
  • Effective leadership skills that promote teamwork.
  • Ability to perform risk assessments and make sound judgments.
  • Familiarity with cGMP and safe work practices.
  • Commitment to continuous improvement.
  • Demonstrated ability to communicate effectively in English.
  • Dependability and initiative in enhancing production processes.
  • Six Sigma or Lean Manufacturing knowledge is a plus.

Physical Requirements:

  • Ability to stand for up to 12 hours per day.
  • Visual acuity (20/30 corrected vision).
  • Frequent activities include sitting, standing, walking, reading, and using a computer.
  • Occasional lifting and moving of up to 30 pounds.

Work Environment:

  • Fast-paced and performance-driven.
  • Customer-focused and collaborative.

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions does not accept unsolicited resumes from agencies or search firms for this job posting. Resumes submitted by third-party agencies without a valid written agreement will become the sole property of Woodstock Sterile Solutions. No fee will be paid for candidates hired as a result of unsolicited referrals.

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