The QC Associate II is responsible for sampling and inspecting for quality incoming raw materials such as active pharmaceutical ingredients, excipients, components, and processing aids. This role is also responsible for creating or revising documents in Alkermes' quality systems such as change controls, deviations, supplier nonconformances, standard operating procedures, and specifications.
Review documentation such as Certificate of Analyses, 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 gloveboxes, 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 visual 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
Write the retain inspection assessment report
Review work of peers, as needed
Create and revise standard operating procedures, technical reports, and specifications, as required
Write supplier non-conformances
Write change controls
Create discrepancy reports and perform Root Cause Analyses
Train other colleagues in methods and procedures
Leads project improvements
Participates in regulatory and internal audits
Works in a safe compliant manner
Use electronic document, inventory and maintenance systems
EMC ApplicationXtender ((AX) - Scanned Document Library))
NuGenesis SDMS - Scientific Data Management System
Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.
Able to handle multiple projects with competing priorities.
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
Able to follow written procedures and exhibit excellent documentation practices.
Able to take on additional tasks, as required.
Able to lift 50lbs
Work well independently or with a group
Able to work safely; seek out and encourage safe practices
Able to pass an eye exam for visual inspection
REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a scientific discipline with 0-2 years' experience in a quality department
Associate Degree in a scientific discipline with 5+ years' experience in quality department
10+ years' experience in a quality department
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.
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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.