Overview
Customer Quality Assurance Specialist Jobs in Largo, FL at PMI Clearwater
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 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
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
#LI-RS1
#Onsite
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 diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.
Degree LevelBachelor’s Degree
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Title: Customer Quality Assurance Specialist
Company: PMI Clearwater
Location: Largo, FL
