Supervisor, Production Operations(2nd Shift)

Kindeva•Brentwood, MO

16h•Onsite

About The Position

At Kindeva, the mission is to make products that save lives, ensuring better health and well-being for patients globally. The company aims to be a world-class, global CDMO, enabling the next generation of medicines through excellence in drug delivery, guided by its vision of Manufacturing More Tomorrows™. This role involves the supervision of a production unit at the Sterile Production Manufacturing (SPM) facility, including support services operations and union operators. The supervisor is responsible for ensuring that production and support services comply with cGMPs and Standard Operating Procedures (SOPs).

Requirements

HS Diploma/AA degree required
3-5 years previous supervisory experience required and/or combination of education and experience
Effective written and oral communication skills required
Excellent written skills in English
Good verbal communication and ability to coach and provide guidance to others
Computer literate, with skills in managing Microsoft Applications, PLS, Trackwise
Demonstrated reading comprehension and writing proficiency at level that meets ‘role’ and/or ‘test’ requirements
Ability to effectively communicate within a diverse group resulting in desired outcomes
Proven record of problem solving, decision making skills and application of process improvement tools
Self-starter, team player, with strong interpersonal and coaching skills

Nice To Haves

Bachelor's degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field
Pharmaceutical or manufacturing experience highly desirable

Responsibilities

Instructs the operations of (union) operators and staff in the daily duties and assures they are performed in a timely manner and in conformance with cGMP at SPM (Sterile Manufacturing Facility).
Departmental duties include prep of sterile components/machine parts and/or sterile filling operations.
Supervises operations to ensure adherence with all Safety requirements when working with autoclaves, Water for Injection (WFI), machine parts and/or sterile fillers.
Immediately addresses all safety events or concerns with Environmental, Health and Safety (EH&S) personnel.
Performs GMP audits of the aseptic processing area and/or supporting areas as required and investigates any process deviations; perform daily reviews of area documentation (including batch records) for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements.
Composes new or revises departmental SOPs as required.
Reports any significant shift activities to the Manager/TL; root cause analysis and ability to define effective corrective/preventative action.
Coordinates personnel activities
Maintains inventory on materials and sterile items used in the at SPM facility.
Sustains and improves labor standards.
Assist with the development and maintenance of the annual department overhead budget and orders supplies for area.
Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed.
Maintain communications with supporting teams (i.e, Work Team Enablers/MRCs for documentation and SOP’s: with Materials and Planning for scheduling of operations and ordering of materials; with Manager/TL to report daily activities and receive information on activities for the area; and with MQA for any quality issues/concerns.
Assists the Production Manager with special projects and other duties as assigned.