Packaging Team Lead, 2nd shift
About The Position
INCOG BioPharma Services is seeking a subject matter expert in sterile drug product packaging. The Packaging Team Lead drives packaging activities for sterile drug products while supporting Packaging Supervision and a team of 6 to 10 associates. The role monitors packaging processes, reviews executed batch records and forms, and helps ensure compliance with quality systems, policies, procedures, and current good manufacturing practices (cGMP). The position is responsible for meeting or exceeding production standards, maintaining product quality, and minimizing or preventing equipment downtime. The Packaging Team Lead collaborates with internal partners, clients, vendors, and cross-functional teams, and may assist with other manufacturing functions as needed. The role is based at INCOG BioPharma’s Fishers, Indiana offices unless otherwise specified. The campus is smoke-free.
Requirements
- High school diploma.
- At least 1 year of GMP pharmaceutical experience in drug product inspection and/or packaging.
- Awareness of regulatory requirements and industry guidance applicable to cGMPs for Combination Products, including 21 CFR Part 4, FDA Guidance for Industry: Current Good Manufacturing Practice Requirements for Combination Products (2015), and ISO 13485:2016 Medical devices — Quality management systems.
- Authorization to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.
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 organization skills and diligence.
- Ability to work with minimal supervision.
Responsibilities
- Support Packaging Supervision and a team of 6 to 10 associates in packaging syringes, vials, and device assemblies.
- Monitor packaging processes and provide daily in-process review of executed batch records and form entries.
- Follow production and manufacturing procedures.
- Perform in-process checks to identify packaging defects and machinery issues, escalating issues to Supervision as required.
- Reconcile finished packaged product and defects.
- Provide input for process and document improvements.
- Operate equipment in compliance with SOPs.
- Ensure compliance with cGMP requirements, quality systems, policies, and procedures.
- Perform labeling and packaging activities for finished product.
- Complete and review associated production records, logbooks, and forms.
- Assist other manufacturing functions as required.
- Train new employees to perform packaging activities.
- 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
Entry Level
Education Level
High school or GED
