QA Specialist IV

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

• 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