Summary
This function is responsible for supporting the daily activities related to the investigations of product complaints. Functions include investigating, batch record review, discrepancy identification, logbook review, and TrackWise Digital trending. This function manages events with Senior Associate for approval of the complaint records.
The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks.
Essential Functions
- Authority to approve written procedures and other documents
- Develop Standard Operating Procedures and other quality related documents.
- Evaluation of batch manufacturing records and testing records
- Follow-up on preventive and corrective actions associated with deviations
- Interact with plant personnel to insure CGMP compliance.
- Prepare and maintain trend analysis
- Provides back up for other QA and plant site personnel as appropriate.
- The monitoring of compliance with the requirement of GMP
- Investigate complaints
Required Education and Experience
- Requires a bachelor’s degree in a scientific discipline or equivalent experience.
Competencies
- Working knowledge of US Drug Product GMP requirements and associated guidelines.
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
- Ability to increase others knowledge of US end European GMP regulations and guidance.
- Strong written and oral communication skills.
- Experience in administration of quality systems for drug product manufacturing and quality control operations.
- Strong written and oral communication skills.
- 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 utilize knowledge and interpersonal skills to provide leadership, direction and development of others
- Good computer skills.
- Good work ethic, dependable, punctual, and flexible.
- Good motivator of personnel.
- Good team player with a can-do attitude.
- Can get things done on the basis of influence.
- Can work in a fast-paced environment with multiple issues open simultaneously.
- Highly organized.
- Attention to detail.
- Identifies opportunities to improve and contributes to problem solving.
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 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.