QA Specialist IV

• Works in the External Biological QA team of Shire United States (US) Quality Assurance supporting, packing and labeling operations, batch release, warehouse operations and logistics performed
• The QA Specialist is responsible for support of appropriate procedures and policies for batch record review and product disposition according to the relevant regional regulations
• Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, and BRAVE values.

Responsibilities-

• This position is responsible for monitoring and supporting batch disposition of bulk drug products (DP) and finished drug products (FDP)
• The individual may be responsible for, but is not limited to: Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record review
• Performing review of bulk drug product executed records, if needed
• Prepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controls
• Reviews and approve deviations and change controls related to DP and FDP
• May own CAPAs associated within the QA unit
• Supports drug product and finish drug product annual review report sections
• Understanding of GMP’s
• Supports departmental projects as needed
• Bachelor’s degree in chemistry, biology or a related discipline
• 6-8 years Quality Assurance experience supporting the manufacture and/or release of drugs, biologics, or devices at CMOs
• Working knowledge of DP and FDP batch record review

• Understanding of quality systems and cGMPs.

• Interpersonal skills and professional skills to interact with customers
• Must be flexible
• Must be able to prioritize and multitask in a stressful environment
• Fluency in English is required
• Significant experience in parenteral biotech manufacturing (aseptic or sterile processing)
• Significant experience working with suppliers and/or contract manufacturing organizations
• Experience with TrackWise and LIMS systems
• Experience with packaging and labeling operations
• Evaluation of batches to ensure completeness, accuracy and compliance
• Evaluation of manufacturing or operational issues for impact and communication to management.

Regards

Ricky