Quality Assurance Specialist II

Curia • Hopkinton, MA

8h • $77,000 - $95,700

About The Position

The Quality Assurance (QA) Specialist II is responsible for maintaining Quality
databases and providing an on-the-floor QA presence and oversight to operations.
This role includes identifying compliance risks in the operation prior to and
during execution, avoiding deviation whenever possible as well as managing
immediate corrective action. The QA Specialist II primarily works in the cGMP
areas to manage adherence to the quality system and assist in and/or initiate
the resolution of deviations.

Curia is a global contract development and manufacturing organization (CDMO)
with over 30 years of experience partnering with pharmaceutical and biotech
companies to provide life-saving treatments to patients. At Curia, we are on a
mission to advance our customers’ therapies from curiosity to cure and
ultimately to improve patients’ lives.

Requirements

• Bachelor’s degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry, OR
• Master’s degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211

Responsibilities

• Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
• Review quality control testing for compliance with internal SOPs and specifications
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
• Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
• Perform and/or participate in internal audits, external audits, investigations, and/or inspections
• With supervision, may respond or manage responses to clients regarding manufacturing, testing and/or documentation issues
• May develop and/or maintain Quality System metrics for management review
• Provide on the floor support to operations, including coordinating and performing day to day activities as needed
• May assist in developing and conducting training of personnel to execute production in full accordance with cGMP’s and Curia’s quality system to ensure real-time compliance
• May perform QA visual inspection activities when required
• Participate in regulatory and client audits
• Other duties as assigned.

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level