Sr.Quality Assurance Associate

• The position is critical to ensuring that Organizational, Site, and Departmental objectives and goals such as Uninterrupted Supply of Product and a Responsive Supply Chain are obtained.

• The Senior QA Associate is an individual contributor with no direct reports.

• Senior QA Associate receives no instruction on routine work as these asks are described in detail in established procedures and standards.

• Receives general instructions on new assignments.

• Provides an independent compliance review of their peer s work prior to final management approval.

• May work on problems and investigations of diverse scope where they exercise judgment within generally defined practices and policies, knowledge of CGMP, job-related experience.

• They independently determine whether the product manufactured by Client meets standards and is acceptable for distribution to Client patients.

• The Senior QA Associate is expected to perform their core job functions with minimal supervision and input from management.

• Reviews executed commercial production records in a timely manner, ensuring that records are in compliance with GMP s and standard operating procedures.

• Upon completion of review, assigns the appropriate disposition.

• Functions as a subject matter expert for the QA department.

• Represents QA on cross-functional department teams and serves as group leader in the absence of department manager.

• Conducts, writes and performs risk assessments for investigations/deviations in collaboration with the production unit to fully understand the impact of any deviation.

• With assistance from the production unit, determines root cause and assigns appropriate CAPA.

• Product Complaints Contacts customers, conducts and writes investigation, trends complaints, collaborates with the production unit to fully understand the impact of the complaint, and with assistance from production unit determines/assigns appropriate CAPA Drafts or contributes to QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data.

• Other duties as assigned to facilitate ongoing Client Baltimore/Gliadel production and/or operational activities including, but not limited to involving Client-Baltimore, ECL, and external partners and companies

• Review Out Of Calibration report, weekly alarm trends and Labeling change controls.

• Executes AQL inspections and sampling Performs Area Clearance and In Process inspections to support Gliadel production

• Periodically summarizes status and progress of assigned activities as requested by supervisor.

• BS/BA or MS in Chemistry, or closely related field required.

• 8+ years of senior level experience in Quality Assurance within the pharmaceutical or closely related industry. Prior supervisory experience preferred, but not required.

• Demonstrated experience performing batch record review and disposition, investigating product complaints and conducting deviation investigations.

• In depth knowledge of CGMPs and Regulatory Guidelines.

• Strong interpersonal and communications skills (oral and written) required.

• Demonstrated excellent customer service skills in dealing with external clients.

• Demonstrated organizational skills.

• Critical thinking and effective decision making skills with ability to identify issues requiring further attention, and ability to initiate and facilitate resolution of those issues in a timely & professional manner.

• Strong attention to detail.

This is a time sensitive and critical position a quick response would be of great help.
Contact Information:
Sneha Shrivastava
Technical Recrutier
(973) 967 3348