Quality Assurance Specialist II

Curia • Rensselaer, NY

9h • Onsite

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.

Requirements

• BA/BS 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 MA/MS 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
• Excellent written and verbal presentation and communication skills
• Strong facilitation skills
• Strong problem-solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers
• Comfortable working independently and proactively in combination with individuals in other departments across the organization
• Focused self-starter with attention to detail and ability to multi-task
• Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211
• Working knowledge of Microsoft Office or other software as needed
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees