Data Reviewer ; QC Job Albany area,New York USA,Quality Assurance

Position: Data Reviewer I (QC)

Data Reviewer I (QC) in Albany, NY

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

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!

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

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 time points 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

Education, experience, certification and licensures Required

· Bachelor's Degree in Chemistry or a related field

Preferred

· One year experience working in cGMP or GLP pharmaceutical industry environment

Other Qualifications

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

Knowledge, skills and abilities

Chemical Hygiene training

Working knowledge and understanding of various…