This global role is responsible for the Quality Assurance Validation (QAV) support to the clinical Pharmaceutical Sciences Biotherapeutic Manufacturing and Laboratory Facilities.
This will include QAV support to all areas including utility, manufacturing (cell bank, drug substance and drug product), laboratory and related computer systems.
This role is responsible for the review of all documentation related to validation activities as well as procedures, change controls, Investigations and commitments.
Candidate is responsible for providing Quality Assurance support to GMP manufacturing and testing operations relative to production and disposition of clinical trial material.
This includes tech transfer and disposition deliverables such as review of batch records, protocols and reports, environmental data, investigations, CAPAs, SOPs, test methods, validation qualifications, change controls, and other GMP documentation to ensure compliance with global board of Health regulations
Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs.
Provide Quality Assurance support for the validation program at the site including utility, manufacturing, laboratory and computer systems.
Primary role includes validation documentation review and approval including specifications, protocols, testing documents, vendor assessments, summary reports, data integrity assessments, higher level validation plans, program documentation and strategies as well as any supporting documentation associated with maintaining of the validated state.
Review and approve change controls, investigations, commitments and procedures.
Responsible for knowing, understanding and acting in accordance with company values.
Support the site relative to a constant state of inspection readiness.
Participate in audits relative to this role as needed.
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities.
Role is primarily office-sitting, standing, walking and bending. This may be inclusive of leading/participating in WebEx meetings.
Minimum Educational Requirements- bachelor’s degree with 5-8 years of experience or master’s degree with 6 years of experience in related engineering or biological sciences.
Ideal candidate would have Biopharma industry experience that includes an understanding of the validation of laboratory and bioprocessing equipment and systems.
In addition, knowledge of global GMP and regulatory requirements related to validation principles as it relates to drug substance and drug product.
Experience in Quality Assurance possessing strong quality culture is desirable.
Team player with strong interpersonal, organizational, and communications skills are a must.
Must have the ability to collaborate and enable quality thinking within the business lines.
Additionally, candidate must be self-motivated, engaged and able to perform moderately complex tasks independently
Team player; multitasker; able collaborate with other teams
Understanding of the quality role for maintaining and onboarding new equipment, instruments and systems.
Able to seek out and assess internal and external compliance with applicable regulations. Contributes to the interpretation of cGXPs for the clinical environment. This includes computerized system and data integrity compliance.
Ability to make quality decisions to resolve issues when choosing between multiple options.
Able to recognize when an issue is beyond their sphere of influence and escalates immediately.
Good communication skills
Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
Ability to independently problem solve and make recommendations for solutions.