Quality Control Lab Technician I - Hopkinton, MA

Quality Control Lab Technician I - Hopkinton, MA

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.

Job Description

The principal responsibility of Quality Control Lab Technician I 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 I 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.

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 with matching contributions Learning platform And more!

Essential Job Duties

Perform microbiological testing (endotoxin, bioburden) for water Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product

Perform environmental monitoring of the clean rooms (under USP and EU specifications) 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

Assist in writing 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

Handle controlled substances including maintaining inventory, completing paperwork, and conducting biannual review 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 Write proposals and design studies for stability

Minimum Education Required

High School/GED

Job Category

Technician

Additional Qualifications/Responsibilities

Education, experience, certification and licensures: Required High school diploma or general education degree (GED) Minimum 0-1 years' relevant experience in a pharmaceutical testing laboratory Preferred Bachelor's degree in Chemistry, Biology or related science