Inspection Team Lead
About The Position
The Inspection Team Lead monitors the inspection process and reviews executed batch records and form entries daily. The role inspects finished product to identify and remove critical, major, and minor defects, while meeting production standards, maintaining product quality, and minimizing equipment downtime. The Team Lead helps the Inspection Supervisor support a daily team of 6 to 10 associates who inspect and package syringes and vials. The position also supports compliance with quality systems, policies, procedures, and cGMP practices, and works collaboratively with internal partners, clients, and vendors. The work includes operating equipment, inspecting filled containers for cosmetic, particle, and integrity defects, reconciling finished product and defects, and completing and reviewing production records, logbooks, and forms. The Team Lead assists with process documents and Knapp and probability-of-detection studies, trains and mentors inspectors and packaging associates, and trains employees on manufacturing inventory transactions in the ERP system. Other duties include supporting manufacturing functions as needed, working in Grade C, Grade D, and controlled non-classified cleanrooms, and performing cleaning and sanitization activities. Flexible hours are required to ensure production facility coverage. The position is based in Fishers, Indiana unless otherwise specified. Applicants must be authorized to work in the United States on a full-time basis; the company does not sponsor work authorization or visas for this role.
Requirements
- High school diploma.
- At least 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging.
- Pass annual health and visual checks, including eye inspections for visual acuity and color blindness.
- Awareness of industry guidance and requirements applicable to visual inspection, including USP <790>, USP <1790>, and FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021).
Nice To Haves
- Previous manufacturing leadership experience.
- Good math and documentation skills.
- Ability to perform repetitive tasks.
- Ability to learn and adapt to innovative ideas.
- Good observation skills.
- Initiative-taking and collaborative approach.
- Effective organizational skills and diligence.
- Ability to work with minimal supervision.
Responsibilities
- Assist the Inspection Supervisor in supporting a team of 6 to 10 associates who inspect and package syringes and vials.
- Follow production and manufacturing procedures.
- Inspect filled product containers for cosmetic, particle, and integrity defects.
- Reconcile finished inspected and packaged product and defects.
- Assist in writing and implementing area process documents.
- Operate equipment in compliance with SOPs.
- Assure compliance with cGMP requirements.
- Complete and review associated production records, logbooks, and forms.
- Assist in performing and documenting Knapp and probability-of-detection studies.
- Train new inspectors according to inspector certification procedures.
- Mentor new inspection and packaging associates.
- Train new employees to perform manufacturing inventory transactions in the ERP system.
- Assist other manufacturing functions, including Formulation, Fill, and Materials, as required.
- Perform duties in Grade C, Grade D, and controlled non-classified cleanrooms.
- Perform cleaning and sanitization activities as needed.
- Collaborate and communicate with cross-functional teams.
- Work flexible hours to ensure production facility coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
