Specialist, Quality Systems

About the role

Join our team as a Specialist, Quality Systems, where you will play a vital role in ensuring the integrity and compliance of our Quality Management System. Provide support within Quality Systems for the processing of Discrepancy reports and CAPA records, ensuring adherence to procedural and regulatory requirements. Collaborate with cross-functional teams, maintain inspection readiness, and provide exceptional support to internal and external customers.

Key Responsibilities

• Update existing channels for tracking Quality Event deviation reports and CAPAs.
• Work with cross-functional teams to maintain adherence to task due dates.
• Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.
• Perform data verification to ensure accuracy of information presented in Quality Events.
• Gather supporting documentation for the investigation of Quality Events.
• Monitor CAPAs to maintain adherence to due dates.
• Perform Effectiveness Checks for existing CAPAs.
• Monitor Continuous Improvement pending items and workflows to ensure closure.
• Update trackers and pull information from Veeva QMS as necessary to ensure Quality Systems team is meeting necessary targets.
• Collaborate with Lead Specialist and Management to establish and meet targets and timelines.
• Ability to manage competing priorities with guidance from leadership.
• Follow company policies and procedures.

Minimum Qualifications

• Bachelor's degree (preferably in Life Sciences field) or equivalent industry experience.
• 2-4 years of experience in Quality Assurance is required.
• Knowledge of cGMPs or equivalent regulations.
• Ability to interpret Quality standards for implementation.
• Skills to independently evaluate situations and propose potential solutions.

Preferred Qualifications

• Leverage critical thinking and strong attention to detail.
• Experience in technical writing and editing skills.
• 2+ years of experience in the biopharmaceutical industry (preferably with biologics).
• Experience in deviation records or CAPA management.
• Ability to work independently.
• Experience in use of quality systems software (quality management systems and/or electronic document management systems).

Who you are

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.