Temp-QA Associate

Alkermes; Wilmington (OH); On-site; USD 27,552 - 34,440; Part time

Job summary

A leading pharmaceutical company in Ohio is seeking a Temp-QA Associate for a temporary position in Quality Assurance. The role involves managing GxP documentation, supporting the documentation lifecycle, and developing quality-related procedures. Candidates should have a Bachelor's degree in a scientific field and 0-2 years of QA experience. Strong communication skills and knowledge of GMP regulations are essential. This is an entry-level role, ideal for motivated individuals.

Qualifications

• Requires 0-2 years’ experience in a Quality Assurance role in the pharmaceutical industry.
• Detail-oriented and able to work in a fast-paced environment.

Responsibilities

• Issuance of GxP documentation.
• Support documentation lifecycle activities.
• Develop Standard Operating Procedures and quality documents.

Skills

Pharmaceutical Quality Assurance

Knowledge of US and European GMP regulations

Strong written and oral communication skills

Support of quality systems

Knowledge of Drug Product GMP requirements

Education

Bachelor’s degree in a scientific discipline

Job description

Overview

Join to apply for the Temp-QA Associate role at Alkermes.

This is a temporary position.

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 / 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.

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.

Seniority level

• Entry level

Employment type

• Temporary

Job function

• Quality Assurance