Quality Control Lab Technician III

The posting

Job Description

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

1. Coordinate all activities associated with the QC stability program, including scheduling and testing of stability lots
2. Act as subject matter expert regarding the stability program during customer/regulatory audits and customer interfacing
3. Provide stability summaries for annual product review and stability data for regulatory filings
4. Serve as designee for the Quality Control Manager as needed
5. 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
6. Analyze data for stability trends and deviations to ensure consistency with historical time points and prevent unexpected results
7. 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
8. Write stability protocols
9. Interact with outside testing laboratories to coordinate shipment and testing of stability samples
10. Develop direct, technical communication with primarily external customers to report results, engage in technical discussion and address questions
11. Review and format reports such as Stability Summary tables to ensure accuracy and compliance with current Curia formats
12. 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
13. Manage sample receipt, storage and associated documentation.
14. Handle controlled substances including maintaining inventory, completing paperwork (DEA 222 forms etc), and conducting biannual and Annual DEA inventory.
15. Coordinate all Controlled substance waste removal.
16. Maintenance of retains and reference standards
17. Create requisitions/POs and order materials for the lab
18. Manage workload and time to enable the incumbent to perform multiple projects effectively and ensure all necessary paperwork is completed on a timely basis
19. Volunteer to assist with other tasks in the analytical function not directly related to specific projects
20. Participate in self-development activities and training others
21. Write proposals and design studies for stability

Education, experience, certification and licensures Required

· Bachelor’s degree in Chemistry, Biology or related science

· Minimum 2-4 years’ relevant experience in a pharmaceutical testing laboratory

Preferred

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

Knowledge, skills and abilities

1. Chemical Hygiene training
2. Other pertinent training/courses
3. Understand of ICH stability guidelines
4. Understand QC stability testing and sample management
5. Ability to work independently and prioritize tasks to meet challenging timelines
6. Demonstrate strong critical thinking, problem solving, communication and decision-making skills
7. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
8. Ability to write routine reports and correspondence
9. Ability to speak effectively before groups of customers or employees of organization
10. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume
11. Ability to apply concepts of basic algebra and geometry
12. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
13. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

Supervisory responsibilities

This position does not have supervisory responsibilities.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; sit; and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. Incumbent may be required to obtain/qualify for and maintain the clearance to wear a respirator at a “class B” level or above following OSHA mandated guidelines.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is frequently exposed to wet and/or humid conditions. The employee is occasionally exposed to moving mechanical parts and risk of electrical shock. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Pay Range: $24.04 - $28.85/hour

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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