Quality Control Lab Technician III

Location: Rensselaer

Quality Control Lab Technician III in Rensselaer, 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 principal responsibility of Quality Control Lab Technician III is the analysis by multiple procedures of intermediates and target compounds. This role is expected to demonstrate expertise in both the theoretical and practical aspects of analytical chemistry. A major component in the scientist's performance rating will be based on productivity. In general, the Quality Control Lab Technician III provides technical, organizational and compliance support for 170+ ongoing stability studies.

The incumbent is encouraged to display a degree of professionalism reflected in part by increasing the scientist's knowledge of theory and practice through reading scientific journals and texts at times beyond the "normal" working hours.

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.

Essential job duties

+ Coordinate all activities associate with the QC stability program, including scheduling and testing of stability lots

+ Act as subject matter expert regarding the stability program during customer/regulatory audits and customer interfacing

+ Provide stability summaries for annual product review and stability data for regulatory filings

+ Serve as designee for the Quality Control Manager as needed

+ Review documentation, analytical chromatographic data and results from instrumental testing such as DSC, XRPD, water analysis, USP testing, etc. for compliance with cGMPs, Curia SOPs and other written procedures

+ Analyze data for stability trends and deviations to ensure consistency with historical time points and prevent unexpected results

+ Manage timelines and multiple projects by Interfacing with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times. Adjust priorities based on due dates and invoicing goals

+ Write stability protocols

+ Interact with outside testing laboratories to coordinate shipment and testing of stability samples

+ Develop direct, technical communication with primarily external customers to report results, engage in technical discussion and address questions

+ Review and format reports such as Stability Summary tables to ensure accuracy and compliance with current Curia formats

+ Manage invoicing for stability, which includes issuing BRFs, working with finance to ensure accurate and complete accounting for stability projects, reviewing monthly invoices and tracking monthly and quarterly financial projections

+ Manage sample receipt, storage and associated documentation.

+ Handle controlled substances including maintaining inventory, completing paperwork (DEA 222 forms etc), and conducting biannual and Annual DEA inventory.

+ Coordinate all Controlled substance waste removal.

+ Maintenance of retains and reference standards

+ Create requisitions/POs and order materials for the lab

+ Manage workload and time to enable the incumbent to perform multiple projects effectively and ensure all necessary paperwork is completed on a timely basis

+ Volunteer to assist with other tasks in the analytical function not directly related to specific projects

+ Participate in self-development activities and training others

+…