QC Analyst

Position: QC Analyst I
Job Description

The QC Analyst 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 1 interacts with multiple departments such as Quality Assurance, Manufacturing, Receiving and Supply Chain. This person is responsible for evaluating information and products and reporting any discrepancies or defects.

Responsibilities:

Follow written procedures

Review documentation such as Cof As, 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

Qualifications:

Bachelor's degree in a scientific discipline required

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

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

About Us
Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our…