Curia
Job Description
Senior Quality Assurance Specialist in Rensselaer, NY
Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
In This Role, You Will
Assist the Quality Assurance Manager in ensuring compliance with all Quality Management Systems and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc.) for the Rensselaer site.
Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs.
Work cross-functionally with other departments on Analytical Quality Assurance activities such as reviewing various documents, protocols, qualifications and/or reports related to Quality Management Systems.
Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
Support all Regulatory Agency inspections at the site and the preparation of CAPAs and monitor the completion of assigned tasks.
Lead and drive GMP activities, work with manufacturing managers and supervisors to complete deviation investigations on time.
Responsible for driving the established quality metrics.
Review and approve master batch records as and when required.
Manage all customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
Report serious or repeated observations or serious compliance gaps to quality management.
Manage the Internal Audit program including coordination of auditors within the QA department.
Interact with the Curia Quality network to share information related to quality expectations, inspections, audits, and harmonization of quality systems within Curia.
Qualifications
Minimum Bachelor of Science degree in Chemistry or a related field
Minimum 8 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA-regulated facilities
Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
Knowledge of pharmaceutical processes.
USFDA inspection experiences (participating or leading)
Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
Proficient in building consensus, negotiating and escalating issues.
Good understanding of the importance and use of quality metrics
Pay Range: $103,000 - $129,300
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
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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Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
In This Role, You Will
Assist the Quality Assurance Manager in ensuring compliance with all Quality Management Systems and Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc.) for the Rensselaer site.
Conduct investigations of OOS, Deviations, Change Control Management, and CAPAs.
Work cross-functionally with other departments on Analytical Quality Assurance activities such as reviewing various documents, protocols, qualifications and/or reports related to Quality Management Systems.
Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
Support all Regulatory Agency inspections at the site and the preparation of CAPAs and monitor the completion of assigned tasks.
Lead and drive GMP activities, work with manufacturing managers and supervisors to complete deviation investigations on time.
Responsible for driving the established quality metrics.
Review and approve master batch records as and when required.
Manage all customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
Report serious or repeated observations or serious compliance gaps to quality management.
Manage the Internal Audit program including coordination of auditors within the QA department.
Interact with the Curia Quality network to share information related to quality expectations, inspections, audits, and harmonization of quality systems within Curia.
Qualifications
Minimum Bachelor of Science degree in Chemistry or a related field
Minimum 8 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA-regulated facilities
Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
Knowledge of pharmaceutical processes.
USFDA inspection experiences (participating or leading)
Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
Proficient in building consensus, negotiating and escalating issues.
Good understanding of the importance and use of quality metrics
Pay Range: $103,000 - $129,300
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
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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