Quality Assurance Specialist II

Job Description Quality Assurance Specialist II – Albany, NY Build your future at Curia, where our work has the power to save lives. 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. We proudly offer 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! 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 Required 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 Pay range: $67,000 - $83,200 Education, experience, location and tenure may be considered along with internal equity when job offers are extended. We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. #J-18808-Ljbffr