Production Supervisor VII

St. Louis, MO, USA Req #1319
Tuesday, June 11, 2024

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows. 

 

ROLE SUMMARY

The purpose of this role is to provide supervision of aseptic support groups and union operators. Responsible for the graded area sanitizer team, unclassified and CNC area sanitation team, and dock attendants assuring processes are performed in compliance with cGMP’s and following Standard Operating Procedures (SOPs).

 

ROLE RESPONSIBILITIES

  • Instructs the sanitizers, sanitation, and dock attendants of (union) operators in the daily duties and assures they are performed in a timely manner and in conformance with cGMP.
  • Supervises operations to ensure adherence with all Safety requirements. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EHS) personnel.
  • Performs GMP audits of the SPM area as required and investigates any process deviations; perform daily reviews of area logbooks for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements when applicable.
  • Composites 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- i.e., vacations, sick time, etc. to ensure there is appropriate coverage in the department at all times; addresses personnel issues as they arise; trains new operators; conducts reviews with operators.
  • Maintains inventory on materials and sterile items used in the aseptic processing area.
  • Maintains and improves labor standards.
  • Assist with 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 MRCs for batch records and SOP’s: coordination of equipment maintenance and repairs with the Tech services group; with QC Lab to coordinate laboratory testing; with materials and Planning for scheduling of sanitizing 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.
  • Aseptic Quality Coaching – continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite.
  • Assists the Production Manager with special projects and other duties as assigned.

BASIC QUALIFICATIONS

EDUCATION & EXPERIENCE

  • Bachelor’s Degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field preferred.
  • Minimum of two years prior work experience; pharmaceutical background. Prior experience in a union shop setting is helpful. Background in manufacturing and supervision is highly desirable.

SKILLS

Language Skills: Effective written and oral communication skills in English required. Good verbal communication and ability to coach and provide

  • guidance to others.
  • Computer Skills: Computer literate, with skills in managing Microsoft Applications, ComplianceWire, Trackwise.
  • Reasoning Ability: Demonstrated reading comprehension and writing proficiency as levels 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

 

 

 

 

California residents should review our Notice for California Employees and Applicants before applying. 
 

Covid-19: 
 

Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
 

Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures. 
 

Equal Opportunity Employer:
 
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Other details

  • Job Family Supervisory I
  • Job Function Management
  • Pay Type Salary
Location on Google Maps
  • St. Louis, MO, USA