Quality Assurance Specialist II - Analytical

Curia • Albany, NY

3d • $63,000 - $78,800 • Onsite

About The Position

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.

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

Nice To Haves

• Knowledge in analytical instrumentation such as XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, and GC

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

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