Temp-QA Associate

Socket.dev; Wilmington (OH); On-site; USD 42,000 - 60,000; Full time

Job summary

Alkermes is seeking a temporary professional to support daily manufacturing operations and quality systems in Wilmington, Ohio. The role focuses on ensuring GxP compliance and maintaining documentation integrity across the product lifecycle.

You will issue GxP documents, assist with the Document Management System, develop SOPs, and help evaluate and improve quality records while collaborating with cross-functional teams in a fast-paced biopharma environment.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.

Responsibilities

• Issuance of GxP documentation.
• Document Management System Support.
• Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
• Develop Standard Operating Procedures and other quality related documents.
• Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
• Support area initiatives and projects.

Skills

QA Experience

GMP Knowledge

Communication Skills

Quality Systems

GMP Guidance

Education

Bachelor’s degree in Science

Job description

This is a temporary position.

This role is responsible for supporting the daily activities related to manufacturing operations and quality systems.

Responsibilities

Key Duties:

• Issuance of GxP documentation.
• Document Management System Support.
• Support documentation lifecycle (Document Scanning, Verification, Retention, and Destruction).
• Develop Standard Operating Procedures and other quality related documents.
• Evaluation of executed documentation (logbooks, controlled forms, and other documentation).
• Support area initiatives and projects.

Skills / Abilities:

• 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 support of quality systems for drug product manufacturing and quality control operations.
• Working knowledge of US Drug Product GMP requirements and associated guidelines.

Personal Attributes:

• 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.

Qualifications

Education:

• Requires a Bachelor’s degree in a scientific discipline or equivalent experience.

Experience:

• 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

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.