Senior Quality Assurance Specialist

Curia, Inc.; City of Albany (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

Curia, a leading global contract development and manufacturing organization, is seeking a Senior Quality Assurance Specialist to oversee quality management systems in the Analytical labs. This role involves cross-functional collaboration, regulatory inspections, and maintaining compliance with FDA standards. Candidates should have extensive experience in the pharmaceutical industry and a strong educational background in life sciences.

Benefits

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching contributions

Learning platform

Qualifications

• Minimum 8 years of related experience in FDA-regulated industry.
• Experience with electronic QMS databases.
• Knowledge of analytical instrumentation.

Responsibilities

• Review and approve various documents related to Quality Management Systems.
• Participate in client audits and regulatory inspections.
• Lead method transfers with minimal oversight.

Skills

Problem-solving

Communication

Initiative

Education

Bachelor’s Degree in Chemistry or related field

Master’s Degree in Life Science or related field

PhD in Life Science or related field

Tools

TrackWise Digital

Analytical instrumentation

Job description

Senior Quality Assurance Specialist (QA/QC) 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!

Summary

The Senior Quality Assurance Specialist (QA/QC) is responsible for the review of various documents, protocols, qualifications and/or reports related to Quality Management Systems in general with a focus on the Analytical labs. This role interacts with clients for quality related issues, as required. The Senior QA Specialist (QA/QC) may be asked to participate in regulatory inspections, client audits and internal audits.

Responsibilities

• Work cross-functionally with the Analytical department on Quality Assurance activities such as reviewing and approval of various documents, protocols, qualifications and/or reports
• Participate in client audits and regulatory inspections
• Assist in the compilation of the Analytical department’s documentation, systems and controls to ensure inspection-ready quality systems (e.g., ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
• Maintain weekly and monthly metrics for the QA efforts within the Analytical department
• Review and Approval of Validation documentation (Method and Equipment) and procedures to increase efficiency while maintaining regulatory requirements
• Work independently to lead & provide direction for method transfers with minimal oversight from management
• A Quality SME for deviations, OOS, OOT, COOT, complaints, change controls in the analytical labs. Ensuring on timeclosure
• Create, revise, review, and approve Standard Operating Procedures(SOPs)
• Perform training at the department level and/or to cross-functional groups as needed
• Identify continuous improvement efforts to build quality in all aspects of the process while considering cGMP/quality compliance
• Coordinate and/or perform day to day activities in conjunction with QA management and provide support to the Analytical department to ensure client timelines are on schedule and attainable
• Recommend and implement methods to increase the quality of the analytical services
• Technical data reviewer of the raw data generated for various compendial testing as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity
• Oversee the implementation of new test methods and specifications at the site

Supervisory responsibilities

This position does have supervisory responsibilities.

Qualifications

• Bachelor’s Degree in Chemistry or related field;
• Minimum 8 years of related experience in an FDA-regulated pharmaceutical, biotechnology and/or medical device industry experience, including 5 years’ GMP and QA experience,
• OR Master’s Degree in Life Science or related field; with minimum 6 years of related experience in an FDA-regulated pharmaceutical, biotechnology and/or medical device industry experience, including 4 years’ GMP and QA experience,
• OR PhD in Life Science or related field with minimum 4 years of related experience in an FDA-regulated pharmaceutical, biotechnology and/or medical device industry experience, including 2 years’ GMP and QA experience
• Minimum 2 years’ experience with electronic QMS databases such as TrackWise Digital (Deviations, OOS, OOT, COOT, CAPAs, Change Controls, Complaints, etc.)
• Minimum 2 years’ experience working knowledge and understanding of various analytical instrumentation including but not limited to XRPD, Particle Size Distribution, NMR, Gas Chromatography (GC), High-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC)

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

Knowledge, skills and abilities

• Working knowledge of Microsoft Office or other software as needed
• Excellent written and verbal presentation and communication skills
• Strong problem-solving skills, with the ability to resolve conflict
• Ability to effectively present information and respond to questions from clients, managers, and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• High degree of initiative with demonstrated ability to work independently, manage multiple projects and meet timelines

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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