We are seeking a detail-oriented QA Co-op to join the Quality Assurance department of our commercial drug product manufacturing facility. The successful candidate will assist in maintaining the integrity and efficiency of our cGMP documentation systems while gaining valuable experience. Required Qualifications:
- Currently pursuing a Bachelor's degree in Life Sciences, Quality Systems, or related field
- Basic understanding of Quality Management Systems and cGMP principles
- strong attention to detail and organizational skills
- Proficiency with Microsoft Office applications (Excel, Word, PowerPoint)
- Excellent written and verbal communication skills
- Ability to follow established procedures and maintain confidentiality
- Demonstrated analytical thinking and problem-solving abilities
- Previous exposure to pharmaceutical or regulated manufacturing environment
- Familiarity with electronic document management systems
- Understanding of 21 CFR Part 11 compliance requirements
- Knowledge of document lifecycle management
- Experience with data entry and records management
- Gain hands-on experience with cGMP documentation requirements
- Develop understanding of pharmaceutical quality systems and regulatory compliance
- Build knowledge of document control processes in a regulated environment
- Experience the document lifecycle from creation through archival
- Network with professionals in pharmaceutical manufacturing
salary: $25 - $32 per hour
shift: First
work hours: 8 AM - 5 PM
education: High School
Responsibilities
- Assist in the processing, editing, updating, tracking, and filing of quality documents according to cGMP requirements.
- Support the document review and approval process through the electronic document management system.
- Participate in document change control procedures and revision history maintenance.
- Assist in periodic reviews of controlled documents to ensure compliance with current regulations.
- Update the Approved Supplier List (ASL) by working with venders and colleagues, comparing to what is in the Inventory Management System.
- Help prepare documentation for regulatory inspections and internal audits.
- Contribute to continuous improvement initiatives for Quality Management Systems Team.
Skills
Qualifications
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.