Packaging Technician I 2nd Shift

GRIFOLS, S.A.•NC-Clayton, CA

8d•Onsite

About The Position

The Packaging Technician inspects manufactured biological products for defects and trends, selects product samples for routine and non-routine quality and stability testing, and performs or verifies product and diluent vial labeling. The role also involves documenting work, maintaining housekeeping standards, and following company safety and current Good Manufacturing Practice (cGMP) policies. Packaging Technicians may set up, operate, troubleshoot, maintain, and change over packaging equipment; package and inspect products; count products; handle products and materials; and deliver samples to Quality Laboratories. Packaging Technician I duties include paced final-container inspections for multiple defect categories, completing required production records and other documentation, and maintaining visual-inspection certification. Higher-grade duties include setting up and operating label-verification systems and equipment such as vial labelers, cartoners, and shrink-banding machines, and conducting periodic system challenges. Packaging Technician II performs Technician I duties and additionally troubleshoots, maintains, and changes over packaging equipment; sets up and operates packaging equipment; uses computer systems such as LIMS and SAP; applies product-specification knowledge to verify components; delivers samples for testing; and evaluates and documents causes of rejected labeling. The position is based in a manufacturing environment and works the second shift, Monday through Thursday, from 3:30 p.m. to 2:00 a.m. Work includes exposure to biological fluids, chemicals, electrical equipment, moving machinery, high noise, and temperatures below 32°F. Required protective equipment includes protective eyewear, safety shoes, gloves, and garments. The role includes prolonged standing and walking, frequent hand and foot movements, lifting and carrying, and occasional bending, twisting, reaching, and entry into confined spaces.

Requirements

High school diploma.
Ability to work effectively as a member of a team.
Pass annual near-vision and colorblindness testing.
Pass initial visual-inspection certification within 90 days of hire.
Identify product defects according to the PDA Lexicon for glass defects and applicable SOPs.
Maintain continuous, concentrated focus on assigned packaging tasks.
For Packaging Technician II, one year of Packaging Inspector or Label Verification Technician experience, preferably in a pharmaceutical or biotechnology environment.
Ability to perform the physical activities described, including prolonged standing and walking, frequent hand movements, and lifting and carrying up to 45 pounds.
Hearing acuity, color perception and discrimination, and near and far vision meeting the stated requirements.

Nice To Haves

Packaging Operator or Packaging Inspector experience for Packaging Technician I.
Packaging Inspector or Label Verification Technician experience in a pharmaceutical or biotechnology environment for Packaging Technician II.

Responsibilities

Perform paced inspections of final-container products for multiple categories of defects and identify defect trends.
Select product samples accurately for routine and non-routine quality and stability testing.
Perform labeling activities and verify product and diluent vial labeling for accuracy.
Document job tasks in Batch Production Records, SOP documents, or other acceptable forms.
Perform housekeeping tasks and maintain department housekeeping standards.
Follow company safety and cGMP policies and practices.
Maintain visual-inspection recertification requirements and identify defects according to the PDA Lexicon and applicable SOPs.
Set up, operate, troubleshoot, maintain, and change over packaging equipment as qualified.
Manually package products and inspect packaged and pre-packaged products for defects.
Accurately count pre-packaged and post-packaged products.
Load and unload products from cages, carts, and boxes; operate material-handling equipment when needed.
Set up and operate label-verification vision systems, vial labelers, cartoners, shrink-banding machines, and related equipment as qualified.
Conduct periodic challenges for packaging systems.
Deliver samples to Quality Laboratories for required testing.
Use computer systems, including LIMS and SAP, to review or enter data.
Apply knowledge of product specifications to ensure correct components are used.
Evaluate causes of rejected labeling and document findings according to SOPs.
Perform other duties as assigned.