Manufacturing Associate

This position involves transforming frozen plasma into freeze-dried plasma. The process includes retrieving frozen plasma from the freezer, thawing it, transferring it into bags, and using a lyophilizer to extract moisture. The final product is repackaged in the kitting room, with each unit meticulously tracked in a BECS system.

Responsibilities

• Champion a safety-driven culture and ensure compliance with safety and environmental regulations.
• Manufacture, inspect, and package products following written processes.
• Maintain a pace that meets or exceeds established time standards while ensuring product quality.
• Build, inspect, and package products using applicable equipment and perform basic visual, dimensional, time, and documentation checks.
• Identify quality issues or workmanship deficiencies related to equipment, assembly, inspection processes, materials, sub-assemblies, and manufacturing environment.
• Comply with GMP requirements by maintaining individual training records, completing data entry in production records timely and accurately, and adhering to documented manufacturing practices and procedures.
• Maintain a clean, safe, and organized work environment.
• Comply with all policies and procedures.
• Cross-train across multiple product lines.
• Perform other duties as assigned.
• Review and improve production procedures, with desk work comprising a significant portion of the responsibilities.

Requirements

• Production and documentation review skills.
• Computer literacy.
• Ability to learn and adapt quickly.
• GMP experience (6+ months).
• GDP experience (6+ months).
• Understanding of SOPs.
• Experience in biologics, pharmaceuticals, or medical devices.
• Ability to read and understand policies, procedures, and processes in English.
• Effective oral and written communication skills.
• Critical thinking and independent decision-making skills.
• Ability to train operators on manufacturing procedures and equipment use.
• Capability to multitask and frequently switch between tasks.
• Ability to sit, stand, walk, bend, and occasionally lift, including entering/exiting the walk-in freezer.
• Demonstrated ability to achieve quality and labor time targets.

Qualifications

• Bio degree or laboratory experience in biology.
• Experience in a highly regulated environment preferred.
• Responsible for accurate documentation in a regulated environment.

Work Environment

The work environment is a cleanroom manufacturing setting where employees will be on their feet most of the day and fully gowned following PPE SOPs.

Schedule

Monday to Thursday, 6 am to 4:30 pm, with the possibility of working on Fridays if needed.

Pay

$25.00 - $25.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract to Hire, fully onsite position based in Maple Grove, MN.