Team Lead, Production – 1st Shift
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Apply Now Application ends in 29d 6h 34min
Job Detail
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Offered Salary 0
Job Description
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Lead all on-floor daily activities as per the production schedule
- Extensive hands-on knowledge of Aseptic filling operations and understanding of first air concepts
- Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), current Good Manufacturing
- Execute daily tasks such as washing/sterilizing vials and filling components for use in production operations.
- Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/postproduction
- Foster team building and provide the necessary training to other staff members as required.
- Recommend revision to batch records and SOPs; suggest regular process improvements
- Perform routine reviews on executed batch records and logbooks.
- Lead implementation of corrective actions and changes
- Generates Purchase requisitions and service receipts for consumables items within the MFG department.
- Perform tasks under minimal supervision, and in a compliant manner to meet production schedule.
- Inform manager on progress of projects, transfer of data, process details, etc.
- Communicate and suggest regular process improvement to management.
- Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
- Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
- Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations.
- Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required.
- As necessary, prepare, clean, or sterilize equipment as necessary for routine aseptic operations
- Restricted Access Barrier System (RABS): Maintain proper gowning qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5/6 areas, and loading/unloading Terminal Sterilization autoclaves and Lyophilizers.
- Isolator: Maintain proper gowning qualifications; Demonstrate aseptic technique and able to conduct cleaning activities in a clean room environment.
- May be called upon to assist in general production activities when necessary.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- BA/BS in any field Or Associate/High School with at least 5-years of experience in a GMP facility
- High interpersonal skills and attention to detail.
- Analytical, organized, self-motivated, and good at multi-tasking.
- Previous experience working with aseptic technique and good documentation practices is required.
- Must be able to follow cGMP regulations during operations including adherence to written procedure
- Must be able to communicate effectively with management and staff.
- Must be able to record data accurately and legibly.
- Demonstrated mechanical aptitude and have manual dexterity.
- Ability to perform in a team setting in a controlled environment for long periods of time.
Preferred:
- Experience in a leadership role in a GMP facility
- Experience in filling using Restricted Access Barrier (RABs) or Filling Isolator Technology
- Experience in preparation of material or equipment in a clean room environment
- Experience in operating Vial Washers, Sterilizing Autoclaves, or Sterilizing ovens
Apply Now
Application ends in 29d 6h 34min