Aseptic Filling Supervisor

POSITION OVERVIEW:
The purpose of this position is to assist with organization and execution of production flows as well as documentation of production results for our operations teams in a ISO 13485/GMP level facility. This is a hand-on position, which will require supporting the team in day-to-day activities, ensuring training compliance, and batch records are completed on time and error free. The individual will also support continuous improvements within the manufacturing team and support process qualifications. We are looking for an energetic, hands-on, knowledgeable problem solver who can assist with the implementation of new filling/finishing labs, SOPs and laboratory equipment as necessary to complete client projects. Strong time management and organization skills along with interpersonal skills are needed for this exciting new opportunity to help create a highly efficient manufacturing team.

JOB RESPONSIBILIITIES:

  • Manage routine manufacturing activities, including day to day scheduling and resource management.
  • Provide leadership when performing component and equipment preparation and aseptic filling duties as needed.
  • Accurately document data and complete batch records as needed.
  • Perform and train other employees in various manufacturing tasks, including, but not limited to: fill/finish, gowning, sanitization, and component and equipment preparation activities.
  • Operate production equipment.
  • Perform and assist in the development of formulation activities.
  • Perform duties within a Class 7 Clean Room with Class 5 Hoods.
  • Execute and author well-defined procedures and assist other technical personnel on issues and problems.
  • Initiate revisions to cGMP/procedure guidelines.
  • Assist in the scheduling and performance of routine maintenance of production equipment.
  • Oversee operations of the production areas, including the warehouse and utility areas.
  • Perform routine performance assessments with direct reports.
  • Define and uphold disciplinary actions for poor performance of direct reports, as necessary.
  • Foster a positive team environment that promotes productivity and employee satisfaction
  • Perform all other tasks, projects, and duties as assigned.

ABILITIES REQUIRED:

  • Prior GMP sterile manufacturing experience preferred.
  • Professional and positive approach.
  • Proven leadership skills.
  • Self-motivated.
  • Ability to follow procedures and regulatory guidance documents.
  • Strong in building relationships and able to communicate at all levels.
  • Team player, and able to work on own initiative.
  • Proficiency in both written and verbal communication and presentations.
  • Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
  • Results oriented and efficient.
  • Ability to work well in a cross-functional team environment.
  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.

QUALIFICATIONS:

  • Qualified candidates have an associate’s degree and 2-5 years of experience in a laboratory environment is required.
  • All prospective employees must pass a background and drug check
  • Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
  • Must be able to stand for extended periods of time over an entire 8 or 10-hour shift.
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a clean room environment.
  • Will work around chemicals such as alcohol that may require respiratory protection.

BENEFITS:

  • Performance-Based Bonuses
  • Referral Bonuses
  • Paid Time Off
  • Paid Holidays
  • Climate Controlled Facility
  • Controlled Access for Employee Safety
  • Convenient Employee Cafe
  • Employee Breakroom with Ping-Pong, Computer Stations, and Televisions
  • Company Events

To apply for this job email your details to jobs@path-tec.com