Clinical Packer Technician

Position Title:

Clinical Packer Technician

Wage: $19.00 per hour

Shift: 1st

Hours:

7:30am-4:00pm

Location:

Bridgewater, MA

About us:

QPS Employment Group is a full-service staffing firm comprised of dedicated and passionate people with over 50 offices throughout the United States. We place great people with great companies in industrial, skilled trades, administrative, manufacturing, general labor and professional employment. Hiring immediately!

Clinical Packer Technician Responsibilities

• Performs clinical packaging activities in a zero-defect environment, ensuring each package meets applicable clinical, quality, customer, and study-specific requirements.
• Performs manual packaging and inspection activities in accordance with approved batch records, work instructions, and established procedures, including operations where automated packaging or inspection technology is not utilized.
• Performs package assembly in accordance with work order specifications, approved procedures, and study-specific blinding requirements. Identifies discrepancies or unclear requirements and escalates questions to the Line Leader or Supervisor prior to proceeding.
• Maintains consistency across packaging activities and related work orders to support clinical blinding requirements, product quality, and study integrity.
• Identifies packaging, quality, or process concerns and communicates issues promptly to the Line Leader or Supervisor.
• Performs clinical packaging activities involving serialized and unique kit numbers, including work orders consisting of multiple individual packaging lots, while maintaining required accuracy and traceability.
• Completes required batch record and work-center documentation accurately and in accordance with company documentation practices and applicable cGMP/GCP requirements.
• Obtains and maintains PAPR certification when required to support applicable products and packaging activities.
• Handles refrigerated and frozen products in accordance with applicable product-handling procedures, temperature requirements, gowning requirements, batch records, and work instructions.
• Performs clinical distribution pack-out activities in accordance with batch records, approved instructions, and direction from the Line Leader or Supervisor.
• Ensures the quality of packaged products by inspecting products and packaging for defects or discrepancies; verifying applicable lot codes and expiration dates are present, legible, and correctly positioned; confirming seals meet established standards; inspecting products and packaging for damage; verifying product integrity and quantities; removing or segregating potentially nonconforming product; and promptly communicating quality concerns to the Line Leader or Supervisor.
• Performs applicable hold and nonconforming-product processes in accordance with established procedures, including identifying and segregating potentially nonconforming product, supporting inspection and approved reprocessing activities, and communicating identified issues to the Line Leader or Supervisor.
• Performs required job and work-center activities, including scanning applicable work orders and employee identification, cleaning equipment and work areas, supporting product and line changeovers, maintaining an organized work environment, and attending required cGMP, safety, quality, and departmental training.
• Follows established safety procedures and utilizes required personal protective equipment and gowning appropriate to the product, process, and work environment.
• Works collaboratively with Line Leaders, Clinical Packer Technicians, Quality, and other team members to achieve production requirements while maintaining safety, quality, compliance, and customer expectations.
• Works overtime and/or weekends as required to support production and business needs.
• Maintains knowledge of and adheres to all applicable PCI policies, procedures, cGMP requirements, GCP requirements, safety standards, quality requirements, and regulatory requirements.
• Maintains regular and reliable attendance, which is an essential function of the position.
• Performs other duties as assigned by the Manager or Supervisor.

Clinical Packer Technician Requirements

• Skills testing requirements met at approved grade level for position.
• Basic mathematical skills.
• Ability to speak in a way that allows one to participate effectively in various conversations.
• Ability to read various types of standard items addressed to general readers.
• Ability to apply common sense understanding to carry out…