CMSC Packaging and Production/Manufacturing Preparation Technician
GSK
July 02, 2026
On-site
Zebulon, NC
Operations
Position Summary:
- Produce clinical trial materials (CTM) for domestic and international clinical trials.
- Perform label printing/inspection and documentation preparation activities to meet required GMP quality standards.
Responsibilities:
- Assure CTMs are produced per packaging orders and applicable regulations.
- Identify problems/deviations and recommend solutions to meet deadlines (no final verification/quality-critical checks unless trained).
- Print and inspect clinical labels; perform bay setup and line clearance.
- Prepare data entry for primary/secondary packaging documentation per GMPs and SOPs.
- Maintain attention to detail and data accuracy.
- Use label/packaging systems (e.g., ClinPro, PTMS, COMET); seek support for system issues.
- Perform routine tasks (e.g., print head checks) on schedule.
- Raise non-standard activities/deviations to team coordinator/supervisor.
- Act as first-line resolution for quality/productivity/safety issues.
- Verify equipment setup (quality-critical settings); complete/verify label reconciliations.
- Anticipate potential equipment/material problems; communicate and consult with supervisor as needed.
- Train/assess trainees; participate in safety risk assessments.
- Identify continuous improvement opportunities.
- Request labels for on-time job completion.
- Support quality investigations (as appropriate); participate in local/regulatory audits.
- Write/obtain approval of observation reports; summarize results and support inter-department projects.
Why You (work model):
- On-site; shift 6:30 am–3:30 pm Mon–Thu and 6:30 am–12 pm Fri.
Basic Qualifications (Required):
- High school diploma or equivalent; Bachelor’s in STEM preferred.
- Experience with GMPs and packaging/labeling regulatory requirements.
- Clinical supplies experience and GMP label creation/packaging operations for clinical trials.
- Basic PC skills; ability to resolve issues in validated systems.
- Technical writing experience for Deviation, CAPA and SOP updates.
Preferred:
- Leadership/people management experience.
- Independent work with minimal supervision; strong prioritization/organization.
- Detail oriented; good interpersonal skills.
- Ability to follow written instructions; strong communication.
- Troubleshooting/problem-solving (with supervision); double-checking accuracy; follow-up/evaluate issues.
- Ability to function on a high-performance team and support change.
- Produce clinical trial materials (CTM) for domestic and international clinical trials.
- Perform label printing/inspection and documentation preparation activities to meet required GMP quality standards.
Responsibilities:
- Assure CTMs are produced per packaging orders and applicable regulations.
- Identify problems/deviations and recommend solutions to meet deadlines (no final verification/quality-critical checks unless trained).
- Print and inspect clinical labels; perform bay setup and line clearance.
- Prepare data entry for primary/secondary packaging documentation per GMPs and SOPs.
- Maintain attention to detail and data accuracy.
- Use label/packaging systems (e.g., ClinPro, PTMS, COMET); seek support for system issues.
- Perform routine tasks (e.g., print head checks) on schedule.
- Raise non-standard activities/deviations to team coordinator/supervisor.
- Act as first-line resolution for quality/productivity/safety issues.
- Verify equipment setup (quality-critical settings); complete/verify label reconciliations.
- Anticipate potential equipment/material problems; communicate and consult with supervisor as needed.
- Train/assess trainees; participate in safety risk assessments.
- Identify continuous improvement opportunities.
- Request labels for on-time job completion.
- Support quality investigations (as appropriate); participate in local/regulatory audits.
- Write/obtain approval of observation reports; summarize results and support inter-department projects.
Why You (work model):
- On-site; shift 6:30 am–3:30 pm Mon–Thu and 6:30 am–12 pm Fri.
Basic Qualifications (Required):
- High school diploma or equivalent; Bachelor’s in STEM preferred.
- Experience with GMPs and packaging/labeling regulatory requirements.
- Clinical supplies experience and GMP label creation/packaging operations for clinical trials.
- Basic PC skills; ability to resolve issues in validated systems.
- Technical writing experience for Deviation, CAPA and SOP updates.
Preferred:
- Leadership/people management experience.
- Independent work with minimal supervision; strong prioritization/organization.
- Detail oriented; good interpersonal skills.
- Ability to follow written instructions; strong communication.
- Troubleshooting/problem-solving (with supervision); double-checking accuracy; follow-up/evaluate issues.
- Ability to function on a high-performance team and support change.