Senior Quality Assurance Associate (Pharma) Job

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Sr. Quality Assurance Associate (Pharma) needed for a contract to hire opportunity with Yoh's client located in Baltimore, MD.

- 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 Eisai meets standards and is acceptable for distribution to 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.

**What You Need to Bring to the Table:** - 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. - Strong interpersonal relationship skills; ability to work effectively across the organization. - Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word and Excel). - Working knowledge of Trackwise desirable. - Ability to work independently with minimal supervision and direction. **The Big Picture - Top Skills You Should Possess:** - 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.