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Temp-QC Associate

4 months ago

Wilmington, Delaware, United States Alkermes, Inc. Full time

QC ASSOCIATE I

The QC Associate I is responsible for sampling and inspecting various incoming materials including but not limited to raw materials active pharmaceutical ingredients, excipients, components, and processing aids. The QC Associate I interacts with multiple departments such as Quality Assurance, Manufacturing, Receiving and Supply Chain. He/she is responsible for evaluating information and products and reporting any discrepancies or defects.

MAJOR RESPONSIBILITIES:

  • Follow written procedures
  • Review documentation such as CofAs, assign expiration and retest dates for incoming raw materials
  • Coordinate the sampling of all incoming raw materials and components
  • Collaborate with Supply Chain, Warehouse, Receiving, Quality Assurance, Operations and the testing laboratory in order to schedule activities.
  • Log samples into Laboratory Information Management System (LIMS), assign testing requirements and enter analytical results
  • Verify raw material labeling such as part and lot numbers
  • Inspect containers for defects and damage
  • Clean sampling equipment and any associated sampling areas
  • Operation of equipment such as glove-boxes, fume hoods, bio safety cabinets and balances
  • Perform sampling for all raw materials, active ingredients, excipients, components, processing aids etc
  • Follow written procedures for sampling techniques and requirements.
  • Perform the visually inspection and dimensional testing of components
  • Operation of equipment such as calipers, tape measure, gauge blocks and sight gauges
  • Identify non-conforming materials at any point in the process
  • Coordinate retain program
  • Prepare and maintain retain samples for raw materials
  • Receive and maintain finished product retain samples
  • Plan, schedule and execute periodic retain inspections in compliance with written procedures for both raw materials and finished products
  • Perform disposals of both raw materials and finished products when appropriate
  • Author and review Standard Operating Procedures, technical reports, specifications, as required
  • Train other colleagues in methods and procedures.
  • Assist in investigating any non-conformances or problems noted during the sampling/inspection process.
  • Use electronic document, inventory and maintenance systems
    • LIMS
    • SAP
    • Veeva
    • Microsoft Word
    • Microsoft Excel
    • Maximo

EDUCATION AND EXPERIENCE:

Associate's degree or equivalent experience required; Bachelor's degree in a scientific discipline preferred.

A minimum of 1 year experience in a pharmaceutical or other regulated industry preferred.

PREFERRED QUALIFICATIONS:

  • Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.
  • Ability to handle multiple projects with competing priorities.
  • Fundamental understanding of mathematics.
  • Intermediate skills in computer use with ability to learn and master new computer applications.
  • Self-directed and motivated, detail oriented, quality minded with strong organizational skills.
  • Effective oral and written communication skills
  • When required, interact with internal and external auditors.
  • Understands paperwork review process.
  • Ability to follow written procedures and exhibit excellent documentation practices.
  • Ability to take on additional tasks, as required.
  • Ability to lift up to 50lbs
  • Work well independently or with a group
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