Quality Control Lab Technician I - Hopkinton, MA

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Job Description

QUALITY CONTROL LAB TECHNICIAN I in 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.

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

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