Quality Assurance Specialist II

POSTED: January 19, 2019
BUSINESS: AMRI
POSITION TYPE: Full-time 
START DATE: Immediate Availability

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Assurance Specialist II is an integral part of the AMRI team, contributing to our success by serving as an
important function to maintain appropriate regulatory documentation.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We
pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and
manufacture.

In this role, you will:

- Perform QA audits of scientific reports/data to ensure cGMP compliance in preparation for release of the reports to the
customer
- Develop, implement, and revise procedures (SOPs, Methods, etc.)
- Conduct investigations and internal audits of quality systems
- Review equipment and software qualification and validation protocols
- Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data
- Conducts employee training sessions as necessary

Qualifications 

Required:

• BS degree
• Demonstrated proficiency in oral and written communication skills producing effective interaction with others at all levels

Preferred:

• Degree in chemistry or other related scientific field
• Previous Quality Assurance or other regulatory experience

All interested applicants must apply online.

AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness.

Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.

 

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