Room Lead, Clinical Packaging (Evening Shift)

HireLifeScience; West Point (PA); On-site; USD 64,000 - 100,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

HireLifeScience in West Point, PA is seeking an experienced Operations Packaging Operator to support Global Clinical Supplies Operations. The Room Lead will supervise a team of Clinical Packaging Technicians, overseeing packaging, labeling, material staging, and documentation to ensure GMP/SOP compliance for all activities.

The role requires hands-on leadership, coaching of new staff, and accurate SAP/MES records, with potential overtime and a 2nd shift on-site five days a week.

Qualifications

• High School Diploma or equivalent required.
• Minimum 1-year experience in GMP regulated environment.
• Leadership experience to enable accountability for daily operations for a team of packaging technicians.
• Excellent communication skills.
• Professional interpersonal skills with ability to address minor disagreements.
• Demonstrate ability to coach, train, and mentor new or junior staff members.
• Maintain vision qualification (20/20 vision with correctives) for gross inspection as well as cleaning qualification.
• Ability to repetitively lift, carry, push and pull up to 50 lbs. required.
• Prior experience in SAP or other similar MES required.
• Ability to quickly learn new systems, equipment, and processes.
• Demonstrated problem-solving skills and a continuous improvement mindset.

Responsibilities

• Facilitate and oversee the execution of filling, labelling, and packaging of clinical packaging jobs.
• Coordinate, perform and document de-packaging, packaging, labeling and sampling activities.
• Ensure other team members within room are performing tasks according to GMP/SOP, batch record instructions, and safety requirements in all activities.
• Accountable to the daily output and product quality within execution of primary and secondary packaging of clinical studies according to internal specifications per Standard Operating Procedures (SOPs).
• Report and prevent potential quality events, non-conformance to GMPs/SOPs.
• Occasional overtime and weekend work may be required.
• Positive interactions with employees within own department as well as frequent interactions with employees from other groups/departments.
• Perform training for new employees and follow up on all daily business-related questions technicians have.
• Handling of controlled substances according to SOP.
• Stage materials for operations, handling products with restricted time out of environment requirements.
• Coordinate, set-up, operate, disassemble and clean area equipment and rooms.
• Ensures accurate documentation of transactions within SAP and paper documents in alignment with Good Documentation Practice (GDP).

Skills

Coaching

Communication

GMP Compliance

GMP Training

Operations Support

Pharmaceutical Manufacturing

Production Scheduling

SOP

Teamwork

Technical Support

Education

High School Diploma or equivalent

Tools

SAP

MES

Job description

HireLifeScience in West Point, PA is seeking an experienced Operations Packaging Operator to support Global Clinical Supplies Operations. The Room Lead will supervise a team of Clinical Packaging Technicians, overseeing packaging, labeling, material staging, and documentation to ensure GMP/SOP compliance for all activities.

The role requires hands-on leadership, coaching of new staff, and accurate SAP/MES records, with potential overtime and a 2nd shift on-site five days a week.