211 Production Coordinator

Pharmgate Inc•Omaha, NE

22h•Onsite

About The Position

The Production Coordinator role is responsible for ensuring compliance with Standard Operating Procedures (SOPs) during all phases of 211 warehousing and production. This includes assisting department management in implementing programs for compliance with company policy and government regulations, and ensuring adherence to the manufacturing schedule. The role involves identifying and correcting process, material, equipment, or skill inefficiencies, overseeing production and labeling accountability, and investigating discrepancies. Additionally, the Production Coordinator manages the receiving and warehousing of components and packaging materials, oversees housekeeping and cleaning programs, and directs preventative and corrective maintenance programs within the 211 Production facility. The position may also require performing the duties of a 211 Production Technician and ensuring compliance with federal, state, local, FDA, cGMPs, and organizational laws and regulations.

Requirements

Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong verbal and written communication skills and the ability to work with all levels of personnel.
Strong analytical and problem-solving skills including the ability to read and understand instructions and materials in English; add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Strong supervisory and leadership skills.
Ability to function well in a high-paced and at times stressful environment.
Thorough understanding of FDA and cGMP compliance regulations.
Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, or other related software.
Associate degree in a related field, or three (3) years equivalent industry work experience required.
3-5 years of coordination/supervisory experience, preferably in a pharmaceutical production facility or other highly regulated industry.

Responsibilities

Maintain fully trained manufacturing staff.
Organizes, directs, and oversees the schedules and work of manufacturing employees.
Provide opportunities for on-the-job training and SOP review as necessary.
Troubleshoot and resolve work problems or assist workers in solving work problems.
Communicate shop floor difficulties, either production or personnel, to production management for resolution.
Know and ensure compliance with the Standard Operating Procedures during all phases of 211 warehousing and production. This includes supervisory duties required by Standard Operating Procedures (SOPs), such as manufacturing verification review.
Assist department management in implementing programs necessary to assure compliance with established company policy and government regulations.
Ensure compliance with the manufacturing schedule established by production management.
Identify and corrects problems and inefficiencies in process, materials, equipment, or skills.
Oversee the production and labeling accountability processes and investigate all discrepancies.
Oversee the receiving and warehousing of all components and packaging materials within the 211 Production facility.
Oversee the housekeeping and cleaning programs within the 211-production facility.
Oversee the preventative and corrective maintenance programs within the 211-production facility and the maintenance of the shop and parts storage.
Perform the duties of a 211 Production Technician as required.
Ensure compliance with federal, state, local, FDA, cGMPs organizational laws, regulations, guidelines, and best practices.
Perform other duties as assigned.