Quality Control Analyst I

Curia • Albany, NY

8h

About The Position

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.

Requirements

• Bachelor’s Degree in Chemistry or science related field
• Minimum 0-3 years’ relevant industrial experience
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience working in a cGMP or GLP pharmaceutical industry experience

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

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
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees