Job Description

Quality Control Analyst I; Data Reviewer in Albany, NY

Build your future at Curia, where our work has the power to save lives.

The Quality Control Data Reviewer I is responsible for supporting the Stability & Reference Standard department and external customers. The principal responsibility of this role is the review and approval of primary analytical data according to cGMP guidelines. The QC Data Reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. This position will also support QA 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 our 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

• Utilize various analytical instrumentation including but not limited to Gas Chromatography (GC), high-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• 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
• Trend stability data to ensure consistency with historical timepoints and no unexpected results
• Verify calculations associated with Stability samples/Reference standards/Raw Materials/Intermediates testing are correctly done
• Format and review Stability summary tables, Stability Protocols for accuracy and compliance with current Curia formats
• Enter data into Stability summary tables. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
• 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 support on QA initiatives (Investigations, change controls etc.) when necessary
• Review and approve test methods, SOPs, forms, and other documents as necessary
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at contract testing labs for stability samples etc.
• Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures

Qualifications

• Bachelor’s Degree in Chemistry or science related field
• Minimum 0-3 years’ relevant industrial experience

Preferred

• Experience working in a cGMP or GLP pharmaceutical industry experience

Other Qualifications

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

Pay Range $52,000-$65,200/yr.

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.

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