QC Associate I at Alkermes, Inc. in Wilmington, Ohio

Job Description:

QC ASSOCIATE I

The QC Associate Iis 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 1 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 degreein 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

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

#LI-DB1

Experience Level:
Associate

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