Senior Quality Validation Specialist

Senior Quality Assurance Validation Specialist 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 Validation Specialist assists with the validation activities throughout the plant, coordinates appropriate support and assists in completing validation activities and provides technical assistance to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues.

Responsibilities 

• Primary responsibility is to provide quality review and approval of validation activities associated with changes to existing systems & projects
• Co-Ordinate with customers related to validation activities to support the overall project timeliness and on-going projects
• Author/review/approve process and cleaning validation protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc.
• Review and approve lab equipment validation protocols/master plans
• Monitor the qualification and validations process to determine accuracy and reliability of equipment, systems, instruments and processes; and make repairs/adjustments based on results
• Review the Annual Product Quality Review as a part of continued process verification for the product performance and recommend process re-validation if needed
• Analyze data and write and/or review final validation reports and summaries for validation protocols
• Develop, review and recommend changes to validation procedures
• Review the Master Batch Records (MBRs) of commercial products and assess the need of process validation based on the proposed process changes
• Conduct special projects as directed by management
• Perform the computer system periodic reviews in coordination with the system admin and the system owner per the master schedule
• Provide technical advice on new and modified equipment and systems to ensure validation/certification and servicing can be provided
• Provide technical assistance and training for personnel on validation activities
• Execute Quality System elements like Deviations and Investigations resulting from process, equipment and utilities qualification and annual requalification protocol execution. Perform investigation on the discrepancies to identify the root causes of problems
• Recommend the CAPAs for the recurring issues in the process or equipment and monitor the successful completion of CAPA and the effectiveness check if needed
• Review and assess any change requests (CRs) from the cross-functional departments and its impact on the current validated state of the equipment/ process/ computer system
• Schedule validations with section supervisors to ensure timely completion with minimal disruption of production schedule
• Recommend changes in policies and procedures, to management, to enhance the company's ability to conform to directives and regulations
• Represent QA Validation and validation strategy during the audit with internal and external customers and during regulatory audits
• Notify and recommend to management course of action when critical instruments, systems or processes are found to be out of specifications
• Interact as needed with outside vendors and consultants

Qualifications:

• B.S. in Engineering or Science related fields (or equivalent)
• Experience: Minimum 5-7 years’ experience in pharmaceutical environment. API industry is preferable (for Curia NY site).  At least 2-3 years of experience in validation or Process Engineering or Quality related discipline or drug development experience is MUST.
• Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in quality concepts including technical & compliance review of documents, expert competence in one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation). Expert in cGMP documentation practices.
• Knowledge of regulations FDA, ICH, ISO 9000-3, PIC/S guides to cGMP, GAMP4 and GAMP 5
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Familiar with validation tools and processes, including equipment qualification, temperature mapping, CPP/CQA studies, and cleaning assessments
• Familiar with FDA and EU regulations for pharmaceuticals and medical devices
• Strong technical writing skills are required to author validation documentation
• Ability to work semi-independently; demonstrated ability to interact well with other technical departments
• Excellent verbal and written communication skills
• Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations
• Ability to utilize MS Office, Databases

Pay Range: 

$84,000 - $105,200

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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Salary : $84,000 - $105,200