Quality Assurance Specialist III (Analytical Labs)

QUALITY ASSURANCE SPECIALIST III (Analytical Labs) in Albany, NY

CURIA provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

We are seeking a highly skilled and experienced Quality Assurance Specialist III (Analytical Labs) to join our Quality team. The ideal candidate will be responsible for technical data review to ensure accuracy and integrity, overseeing the implementation of new test methods, and conducting internal audits to maintain compliance with cGMP and SOP requirements. The successful candidate will possess strong communication, problem-solving, and technical skills, with proficiency in analytical instrumentation such as XRPD, PSD, DSC, HPLC, GC, NMR, and ICP-MS. 

This role serves as a subject matter expert (SME) in managing deviations, OOS/OOT/COOT incidents, complaints, and change controls within our analytical labs, ensuring timely and compliant resolutions. Key responsibilities include supporting regulatory and customer audits, reviewing and approving equipment qualification and calibration records, and contributing to the creation and revision of Standard Operating Procedures (SOPs).

 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

 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
• Learning platform
• And more! 

Responsibilities:

• A Quality SME for deviations, OOS, OOT, COOT, complaints, change controls in the analytical labs. Ensuring on time closure.
• Assist in technical data review of the raw data generated for various compendial testing as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity. 
• Oversee the implementation of new test methods and specifications at the site
• Conduct internal audits and walkthroughs in the analytical labs to ensure documentation, practices, and procedures follow SOPs and cGMPs, review progress toward closure of audit findings and communicate the results of internal audits to appropriate management
• Review and approve IQ, OQ, PO, maintenance, and calibration records of the analytical instruments
• Assist with Regulatory and Customer audits as required.
• Create, revise, review, and approve Standard Operating Procedures (SOPs)
• Recommend changes to all applicable SOPs; review and approve documentation to support business needs, and evaluate documents for completeness and accuracy
• Perform training at the department level and/or to cross-functional groups as needed
• Complete assignments within department cycle times and maintain a high level of quality detailed documentation

Knowledge, Skills, & Abilities:

• Effectively communicate with coworkers, customers and quality assurance work teams; participate in one department level committee
• Ability to effectively present information and respond to questions from groups of managers and customers in both large and small groups
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedures and independently prepare and issue written communications, in accepted grammatical style, which need little or no editorial corrections and submit for review by supervision or a designee prior to being issued
• Ability to verbally express ideas, facts and proposals in a clear, logical, and concrete manner
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• Proficient in the use of MS Word, Excel, Access, and other software as needed
• Proficient in problem solving techniques and the ability to troubleshoot with limited supervision, requiring some independent judgment. Actions to be taken will be discussed with supervisor before resolving non-routine problems
• Proficient in time management for multiple tasks, respond to high priority tasks when necessary and deliver assigned tasks on time

 Qualifications and background to be successful in this role:

• Requires