Supervisor QA Inspections - NW Indy
- Immediate Opportunities - Life Sciences
- IN, USA
- Full Time
Supervisor QA Inspection - Exelead
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for a Supervisor in QA Inspection. (Level will be determined based on candidate's qualifications).
This position is responsible for leading the Quality Inspection team within a complex parenteral manufacturing facility and providing functional leadership of Receiving Inspection, Manufacturing line clearance activities, and related investigations/CAPAs. In addition, this position provides Quality oversight for all aspects of warehouse operations, raw materials, utilities and facility releases. The individual champions continuous improvement activities with quantitative results that consistently deliver low cost, defect free products on-time. The position is a working supervisory position that supports production and warehouse operations with a goal to optimize inspection resources and lead, the change from inspection control to process control. The position collaborates with other QA personnel, Quality Control, Operations, Clients and Suppliers to establish and maintain requirements, for raw materials, components, manufacturing processes, and finished goods. Reporting to the Director of Quality, the leader must have the ability to effectively communicate up and down the organization across all functional areas.
• Oversees/performs inspection activities for raw materials, in process and finished goods. Provides direct QA oversight of manufacturing and warehouse areas including performance of manufacturing down the organization across all functional areas.
• Oversees/performs inspection activities for raw materials, in process and finished goods. Provides direct QA oversight of manufacturing and warehouse areas including performance of manufacturing line and room clearance activities and AQL sampling inspections. Ensures all duties are performed in accordance with cGMP.
• Provides Quality oversight for all aspects of warehouse operations, raw materials, utilities and facility releases.
• Supervises and performs the activities of the department including customarily and regularly directing, advising, and managing direct subordinates, as well as providing performance feedback and for recommendations for promotions and/or pay increases.
• Assesses departmental productivity and efficiency in order to provide on time delivery of services by the department. Participates in the appropriate selection and usage of resources (materials, systems and/or equipment) required for the effective operation of the department.
• Provides for team member safety by promoting safe work practices, monitoring compliance with EHS policies, and minimizing physical hazards to promote an overall safe work environment.
• Monitors Quality Assurance programs to ensure process controls are met, documents activities, and brings about corrective action as needed. Monitors Quality Assurance programs for incoming material inspection.
• Assists in audits, documents audit results, and provides input and recommendations for necessary corrective action as needed.
• Supervises activities of Quality Assurance inspectors.
• Performs special projects and other duties as assigned.
• As a part of the employee's job requirements, the employee may be required to handle wastes
• including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
Supervises three employees in the Quality Inspection area. Carries out all supervisory
responsibilities in accordance with the organization's policies and applicable laws.
• Bachelor's Degree in Science or related field.
• Three to five years of progressively more responsible quality assurance experience required.
• Previous experience with inspection activities and usage of SAP for inspection functions desired.
• Experience within an aseptic manufacturing environment and warehouse GMP controls preferred.
• This person must be able to operate with a high level of autonomy.
• Essential knowledge of cGMPs.
• Ability to work with mathematical concepts such as fractions, percentages, ratios, proportions to practical situations.
• Demonstrated written and verbal communication skills as well as computer literacy (e.g. Microsoft, Access, Excel, Word, and PowerPoint) are required.
• Ability to read, analyze and interpret general business periodicals, professional journals,
technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers,
clients, customers, and the general public.
• Physical Demands: employee will be required to stand, walk, sit, reach hands and arms, climb or
balance and stoop, kneel, crouch or crawl. Occasionally the employee must lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and ability to adjust focus.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
Full package of benefits
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