What are the responsibilities and job description for the Temp-QC Associate position at Alkermes?
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
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