Inspection Manufacturing Supervisor

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Inspection Manufacturing Supervisor is directly responsible for supervising shift inspection operations for the Maryland Heights, Missouri site. All activities must comply with cGMP, internal and both domestic and international regulatory requirements. The position requires supervision of organized labor to ensure that the manufacture of products complies not only with cGMP's but also that labor and material standards are met, and that planned production occurs on time to meet forecasted sales.

This leader acts as primary technical subject matter expert for AVI/MVI processes and the Inspections program during regulatory inspections/audits and must have the ability to communicate effectively not only within the department but cross functionally at the site and with outside customers and regulatory agencies.

• Operations and Supervision
• Supports,coaches, and develops
  
  Inspection Colleagues to improvecolleagueengagement,ability, andgrowththat results inimprovedbusiness success.
• Perform operational functions to meet daily and weekly production schedule activities including product check-in and in-process tests.
• Foster continuous process improvement, decrease cost, and improved product quality through application ofOpExprinciples.
• Effectively coordinate activities by communicating with other operational departments.
• Ensure adequate levels of operating supplies to meet production needs.
• Train staff on good safety practices and enforce all safety regulations.
• Write departmental procedures and batch records for the department.
• Maintain and improve labor standards for the operating departments.
• Work 1st, 2nd,3rdor Split shift as needed to support operations andcomply with production schedule.
• Work daily and weekend overtime, as needed, to effectively manage operations, complete production documentation, and achieve production goals.
• Regulatory Inspection Readiness & Compliance
  • Supports and develops Inspection Program strategy, standards, anddefect detection philosophy.
  • Actsas primary SME for AVI/MVI during regulatory inspections and audits.
  • Supports AVI/MVI during regulatory inspections and audits
  • Ensure inspection programs align with cGMP, internal quality systems, and global regulatory expectations.
  • Author, review, andapproveinspection-related SOPs, protocols, and reports

• Associates degree (or higher) in Engineering, Life Sciences, or a related technical discipline
• Pharmaceutical manufacturing experience
• Good verbal communication and ability to coach and provide guidance to others.
• Proven record of problem-solving, decision-makingskillsandapplication of process improvement tools.
• Prior experience in a union shop setting is helpful.
• Must have the ability to work effectively under andmanage tostrict production, time, and performance deadlines.
• Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.

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.

Job Family D
- Packaging Operations
- Packaging & Inspection