Quality Assurance Specialist II - Analytical

Quality Assurance Specialist II - Analytical in Albany, NY Build your future at Curia, where our work has the power to save lives. The Quality Assurance (QA) Specialist II (Analytical) is responsible for review and approval of primary analytical data according to cGMP guidelines. The ideal candidate will be responsible for technical data review to ensure accuracy and integrity, overseeing the implementation of new test methods to maintain compliance with cGMP and SOP requirements. The candidate will possess strong communication, problem-solving, and technical skills, with knowledge in analytical instrumentation such as XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, and GC. This position will also support Quality initiatives when necessary and collaborate with laboratory personnel to review data per cGMP compliance and data integrity. The Reviewer should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. In addition, the Reviewer will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for Curia customers. 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 * Review quality control testing for compliance with internal SOPs and specifications * Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity * Collaborate with lab personnel for data review per cGMP compliance, data integrity * Ensure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures * Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures * 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. * Provide support on Raw Material release and GMP production suite commissioning activities when necessary

• May perform QA cleaning verification and inspection activities when required
• Other duties as assigned

Qualifications * 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
• Strong time management and organizational skills with the ability to

multi-task and manage multiple projects independently * Ability to meet deadlines and work under pressure with limited supervision Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $63,000-$78,800 annually 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. All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.