Sr. Quality Assurance Specialist (QSC)
This position will primarily support the Vendor Management Program across clinical and commercial operations. May assist in other areas of quality systems and compliance, including but not limited to, deviations, CAPAs, change control, and inspection readiness/management. Works on assignments that are complex in nature where judgment is required in resolving problems and making recommendations. Normally receives no instruction on routine work and provides recommendations on new assignments.
- Maintains the internal and external audit schedules.
- Reviews, assesses, and coordinates audit questionnaires in accordance with vendor management and monitoring program.
- Authors vendor assessments for questionnaires reviewed.
- Performs internal audits and external audits as needed.
- Authors audit reports for internal and external audits performed.
- Coordinates external audits with consultant auditors.
- Tracks vendor change notifications and communicates them to impacted functional areas for impact assessment.
- Routes vendor and consultant contracts (e.g. NDA, SOW) in Contracts Management System and tracks timely approval of contracts.
- Generates metrics related to internal and external audits.
- Supports the review and approval of quality system records (e.g. Deviations, CAPA, Change Control, etc.).
- Supports inspection readiness/management.
- Participates in developing and improving Standard Operating Procedures to ensure quality objectives are met.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives, current Good Manufacturing Practices (GMPs) and applicable regulatory requirements.
- Works directly with operating entities to ensure that compliance commitments are met on a continuing basis as specified to enforce requirements.
- Applies company policies and procedures to resolve a variety of moderately complex issues. Exercises good judgment in selecting methods and techniques within defined procedures and practices to determine appropriate action.
- Keeps abreast of requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of compliance questions and issues.
BA/BS or equivalent combination of related education and experience.
- At least 7 years of relevant experience in the pharmaceutical/biotech industry or equivalent combination.
- Experience in internal and external audits, including questionnaire review.
- Works under limited supervision; demonstrating a level of independence and providing recommendations for continuous improvements.
Knowledge, Skills and Abilities
- Demonstrates proficiency in application of QA systems principles and standards, current industry practices, and applicable regulations including 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.
- Comprehensive knowledge of audit standard, practices and principles.
- Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Effective time management, organizational and planning skills.
- Possesses initiative and is proactive.
- Builds productive internal and external working relationships.
- Must work effectively within teams with rapidly changing priorities.
- Demonstrates good coping skills and analytical problem-solving skills.
- Experience with databases and has advanced knowledge of the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.).