Drug Product Manufacturing Associate I - 1st Shift

PCI Pharma Services•San Diego, CA

About The Position

The Manufacturing Associate I executes GMP production of injectable pharmaceuticals by following applicable SOPs. The role prepares equipment and materials for aseptic production and operates equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines. Associates train in one or more areas of aseptic manufacturing in an FDA-regulated facility, complete required training, and carry out routine manufacturing tasks on complex equipment under established SOPs and cGMP regulations. The position works in cleanroom environments, accurately documents data and batch records, and handles laboratory waste according to established procedures. This is an evergreen posting intended to build a pipeline of qualified candidates for current and future opportunities; candidates may be contacted as business needs arise.

Requirements

  • High school diploma required.
  • Zero to two years of relevant experience in manufacturing, laboratory, mechanical, or engineering positions.
  • Ability to follow instructions with direct supervision.
  • Detail orientation and strong written and verbal communication skills.
  • Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
  • Familiarity with cGMP, manufacturing, machine operations, and data entry.
  • Familiarity with Microsoft Office applications.

Nice To Haves

  • Bachelor’s degree in a science or engineering discipline preferred.

Responsibilities

  • Train in one or more areas of aseptic manufacturing of injectable pharmaceuticals using GMPs in an FDA-regulated facility.
  • Complete required SOP training and execute the training curriculum.
  • Prepare materials needed for aseptic operations.
  • Perform routine manufacturing tasks on complex equipment in accordance with SOPs and cGMP regulations.
  • Accurately document data and complete batch records as needed.
  • Follow well-defined SOPs and operate in cleanroom environments according to established policies and procedures.
  • Collect and dispose of laboratory waste according to established procedures.
  • Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
  • Align daily actions with department goals and company culture.
  • Maintain regular and reliable attendance on a full-time basis or in accordance with the posted schedule.

Benefits

  • Paid time off
  • Health insurance coverage, including dental and vision
  • Flexible spending account
  • 401(k) plan
  • Eligibility for an annual performance bonus
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