Inspection Manufacturing Supervisor

Kindeva Drug Delivery•Maryland Heights, MO

1d•Onsite

About The Position

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.

Requirements

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-making skills and application of process improvement tools.
Must have the ability to work effectively under and manage to strict 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.

Nice To Haves

Prior experience in a union shop setting is helpful.

Responsibilities

Supports, coaches, and develops Inspection Colleagues to improve colleague engagement, ability, and growth that results in improved business 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 of OpEx principles.
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.
Maintain good departmental housekeeping.
Work 1st, 2nd, 3rd or Split shift as needed to support operations and comply with production schedule.
Work daily and weekend overtime, as needed, to effectively manage operations, complete production documentation, and achieve production goals.
Supports and develops Inspection Program strategy, standards, and defect detection philosophy.
Acts as 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, and approve inspection-related SOPs, protocols, and reports