Work Location: Indianapolis, Indiana Shift: No Department: LS-SC-POEMM Indianapolis Manufacturing Systems Recruiter: Katherine Hall
Hiring Manager: Nikhil Sabu
This information is for internals only. Please do not share outside of the organization.
Your Role:
The production coordinator is responsible for coordinating and possibly expediting the flow of paperwork and materials within the manufacturing department and between support departments to meet the production and product release schedules. The coordinator ensures that all materials and supplies are provided in a timely manner to maintain the appropriate production levels and ensure customer commitments are met.
Responsibilities include but are not limited to:
Controls the incoming and outgoing documentation process, reviewing production batch records, maintaining production supplies inventory, ordering supplies which are non GMP in nature, collecting department metrics, resolution of deviations, providing administrative and office support for the manufacturing department, receiving, and directing visitors, and change control administration.
Provides an additional level of redundancy within the Manufacturing Department by serving as a back-up Supervisor during periods of vacation, short-term disability, turnover, etc.
Provides interim supervision of department activities for members of the manufacturing team.
Coordinates manufacturing activities with other support groups to receive components, batch records, QC results, etc.
Executes tasks/operations with minimal supervision.
Assumes ownership of area batch record review and approval, minimizing documentation and recording errors prior to delivery to QA.
Performs review and reconciliation of all batch related materials in SAP in a timely manner.
Schedules and coordinates flow of work within or between departments to ensure production schedule is met.
Performs the delivery, prioritization, re-assembly, and postproduction review of master production records.
Distributes work orders to departments.
Compiles department metrics to evaluate performance.
Compiles department metrics and provide to daily Tier meetings in a timely manner.
Responsible for capturing and entering batch record data into tracking databases.
Compiles reports concerning progress of work and downtime due to failure of machines and equipment to appraise production planning personnel of production delays.
Maintains inventory of materials and parts needed to complete production, including laundered gowns and plant uniforms.
Acts as a liaison for manufacturing management and production technicians.
Ensures compliance to company policies, FDA regulations, GMP's, and all safety standards.
Who You Are:
Minimum Qualifications:
Associates Degree in any discipline and 2+ years of pharmaceutical experience.
OR
Bachelors Degree in any discipline.
Preferred Qualifications:
3+ years of experience in a regulated GMP environment (food or pharma).
3+ years of experience involving inventory control, batch record handling/reviewing, and work order processing.
3+ years of Microsoft Office Suite experience.
3+ years of experience with ERP systems.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
