GMP Manufacturing Associate I

ProMed Molded Products, Inc.•Plymouth, MN

6h•$21 - $28•Onsite

About The Position

The GMP Manufacturing Associate I performs hands-on assembly, packaging, inspection, cleaning, and documentation work on the GMP manufacturing floor to safely and accurately produce drug products and combination devices. Working under the direction of senior production staff, the role follows approved batch records, work instructions, and standard operating procedures, while upholding cGMP requirements and Good Documentation Practices. The Associate helps protect product quality, safety, and compliance and maintains manufacturing areas in an inspection-ready state. The position includes manual and semi-automated assembly; primary and secondary packaging, including kit assembly, labeling, and cartoning; in-process inspections; line setup, changeovers, and line clearance; material verification and reconciliation; equipment, tool, room, and controlled-environment cleaning and sanitization; and accurate, real-time completion of production and cleaning records. The Associate maintains required training and qualifications, escalates equipment malfunctions, process deviations, and quality issues, and is expected to attend reliably and perform other appropriate duties as needed. The role is performed indoors in pharmaceutical manufacturing and packaging areas, including cleanrooms, controlled production areas, and warehouses where chemical substances, including active pharmaceutical agents and cleaning agents, are used. It requires extended periods of repetitive work, wearing PPE and cleanroom garments, and the ability to work flexible schedules, overtime, weekends, or shift work as business needs require. The listed shift is 1st shift.

Requirements

High school diploma or equivalent.
At least 1 year of experience in pharmaceutical, biotechnology, medical device, food manufacturing, or another regulated manufacturing environment.
Ability to read, understand, and follow SOPs, batch records, and work instructions in English.
Ability to accurately complete GMP documentation following Good Documentation Practices.
Strong attention to detail and commitment to product quality.
Fine motor skills in hands and wrists and good hand/eye coordination.
Basic computer skills.
Ability to work independently within established procedures and meet deadlines and priorities.
Ability to safely perform required movements, including standing, sitting, walking, stooping, bending, squatting, kneeling, reaching, grasping, lifting, pushing, pulling, and repetitive movements for extended periods.
Ability to occasionally lift and move materials weighing up to 35 lbs.
Ability to wear required PPE and cleanroom garments for extended periods.
Visual acuity, with or without corrective lenses, to read handwritten or typed material, adjust focus, and perform visual inspection.
Hearing and speech sufficient for continuous communication on the manufacturing floor.
Ability to move around the building, maneuver in tight spaces between equipment, and walk on even or uneven surfaces.
Ability to work indoors in pharmaceutical manufacturing and packaging areas, including cleanrooms, controlled production areas, and warehouses where chemical substances are used.
Ability to sustain concentration and attention to detail during repetitive assembly, inspection, and documentation tasks.
Ability to work flexible schedules, overtime, weekends, or shift work as business needs require.

Nice To Haves

Experience in a pharmaceutical manufacturing environment.
Experience with combination drug product assembly and packaging operations.
Experience with visual inspection, including manual and automated systems.
Experience using a microscope or reticle.
Experience working in controlled manufacturing environments or cleanrooms.
Knowledge of pharmaceutical cGMP standards and Good Documentation Practices.

Responsibilities

Read, understand, and follow approved batch records, work instructions, and SOPs for drug product and combination-device production.
Perform manual and semi-automated assembly operations.
Perform primary and secondary packaging, including kit assembly, labeling, and cartoning.
Perform in-process inspections and quality checks as required by production procedures.
Conduct line setup, changeovers, and line clearance activities.
Verify the availability and accuracy of materials, components, equipment, and production documentation before manufacturing begins.
Reconcile components, labels, and finished goods according to established procedures.
Follow gowning requirements and contamination-control practices in controlled manufacturing areas.
Clean and sanitize manufacturing equipment, tools, production rooms, and controlled environments.
Maintain a clean, organized, inspection-ready work environment consistent with GMP housekeeping standards.
Complete production records, logbooks, cleaning records, and other documentation accurately and in real time according to Good Documentation Practices.
Promptly correct documentation errors identified by leads, supervisors, or Quality reviewers.
Maintain training and qualifications required for assigned manufacturing operations.
Escalate equipment malfunctions, process deviations, and quality issues to supervision and Quality Assurance personnel.
Meet expectations for regular, reliable attendance and perform other duties as needed.
Support on-time scheduled production and maintain adherence to gowning and contamination-control practices.