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 Bachelors 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

Job Tags

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