QC Compliance Specialist

Job Description Summary

Supports the core quality systems including: investigation/deviation management general CAPA support incident management controlled document writing/review change control support oversight of vendor work order system

Job Description

• Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence. Employs standardized root cause analysis investigation tools and methodologies. Own CAPAs as appropriate.
• Utilizes Investigation and Deviation systems for owning QC investigations tracking statuses leading investigations teams and serve as QC liaison with other department investigation writers to ensure complete and timely resolution.
• Participates in lean lab operation and continuous improvement programs to eliminate non-value-add activities/maximize efficiency.
• Provides technical support with assigned area of QC.
• Provides support with assigned business process systems to support QC. These systems include SAP LIMS Data Historian and Trackwise.
• Responsible for the Work Order Tracking system for tracking and coordinating the initiation execution and completion of work orders.
• Complies with policies and procedures in order to maintain compliance with legal regulations health and safety and regulatory requirements as written.
• Responsible for reviewing trends of QC deviations and investigations to identify areas requiring additional action.
• Maintains departmental metrics and key performance indicators (KPIs) for Senior leadership review.
• Owns develops and maintains controlled documents.

Minimum Requirements:

• Bachelors degree and 2 years experience or equivalent (minimum).
• Basic knowledge of cGMP and FDA requirements preferred
• Knowledge of Laboratory Systems and Investigation/Deviation writing required
• Excellent organizational planning and time management skills.
• Strong oral written and interpersonal communication skills. Demonstrated technical writing skills.
• The ability to work effectively in both a team environment and an individual contributor role.

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

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At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

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CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus