Overview
Enterprise Operations Quality Control Specialist – On-Site, Birmingham Jobs in Hoover, AL at Regions
Overview:
Job Description: This function is responsible for supporting the daily manufacturing and facility operations along with project support. Functions include proactive support of change control assessments, documentation reviews and validation review/support. Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise Deviations, and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.
Responsibilities:
Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
Identifies compliance risks and develops sound rationale as basis for audit observations.
Supports the coordination activities and assists with interactions during regulatory agency inspections
Perform internal audits and author annual product reviews.
Participates in the review and revision of Compliance-related controlled documents.
Qualifications:
Minimum Education & Experience Requirements: Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 5 – 8 years’ experience in a Quality Assurance role in the pharmaceutical industry.
Knowledge/Skills Needed: Strong written and oral communication skills. A thorough understanding of the regulatory process from GLP through commercial manufacturing. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Experience in sterile and aseptic product qualification and quality. Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines. Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations. Project management experience including scheduling, tracking and auditing. Experience in change management and deviation resolution including CAPA systems. Experience in participating in pharmaceutical technology transfer teams. Experience in the qualification of facilities, utilities, equipment and processes.
Personal Attributes Needed: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Ability to increase others knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMP’s. Demonstrated leadership skills with a high degree of independence and limited oversight. Demonstrated success with increasing levels of organizational responsibility.
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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: Enterprise Operations Quality Control Specialist – On-Site, Birmingham
Company: Regions
Location: Hoover, AL
