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