Quality Control Lab Technician III

Curia • City of Rensselaer, NY

5h • $24 - $29 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Chemistry, Biology or related science
• Minimum 2-4 years’ relevant experience in a pharmaceutical testing laboratory
• Chemical Hygiene training
• Other pertinent training/courses
• Understand of ICH stability guidelines
• Understand QC stability testing and sample management
• Ability to work independently and prioritize tasks to meet challenging timelines
• Demonstrate strong critical thinking, problem solving, communication and decision-making skills
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write routine reports and correspondence
• Ability to speak effectively before groups of customers or employees of organization
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
• Ability to apply concepts of basic algebra and geometry
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Nice To Haves

• Master’s degree in Chemistry, Biology or related science

Responsibilities

• 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
• Write proposals and design studies for stability

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level