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Sr. QA Associate

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Company :
Eisai Inc (Starpoint)

Location :
Baltimore, Maryland

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
Our client is looking for a Sr. QA Associate for their Baltimore, MD location. Responsibilities: – Prepares, reviews and issues required documentation such as good practice quality guidelines and regulations (GxP), and change authorizations in accordance with company policy and government regulations for commercial Pharmaceutical organization. Implements related documentation systems. – Provides input on quality control procedures. – Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. – Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. – Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. – Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. – Ensures the quality assurance programs and policies are maintained and modified regularly. – Facilitates uniform standards and enables best practice sharing, thereby fostering the achievement of company’s mission globally. – Performs detailed audits of practices to ensure that policies and procedures comply with guidelines set forth by regulatory agencies. – Works with product safety evaluation and reports on weaknesses, ineffective procedures, policy exceptions and reporting discrepancies and recommends appropriate corrective actions. – Consults with laboratory management to establish practices and procedures that comply with regulatory agencies. – – Performs batch/lot record review to ensure that all reviewed records have been executed per procedure and meet all quality requirements. – Responsible for the disposition decision for commercial product manufactured at Client location. – Conducts investigations in collaboration with the production unit to fully understand the impact of the deviation and determine appropriate CAPA. – Investigates product complaints and conducts follow-up with customer. – Drafts or contributes to QA documentation, including investigation reports, standard operating procedures, and annual product reviews (APR)/product quality reviews (PQR). Trends Quality data. – May represent QA on cross-functional department teams and function as group leader in the absence of department manager. – Trains other QA personnel on procedures. Requires minimal direction and supervision. – 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 Sr. QA Associate is an individual contributor with no direct reports. – Will 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. – Independently determine whether the product manufactured by The Client meets standards and is acceptable for distribution to The Client’s patients. The Sr. QA Associate is expected to perform their core job functions with minimal supervision and input from management. Essential Functions – 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. – 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. – Represents QA at departmental meetings and on cross-functional department teams involving The Client and external partners – Review Out Of Calibration reports, weekly alarm trends and Labeling change controls – Executes AQL inspections and sampling – Performs Area Clearance – Periodically summarizes status and progress of assigned activities as requested by supervisor. Requirements – BS/BA or MS in Chemistry; or closely related field required – 8+ years of senior level experience providing Quality Assurance for commercial Pharmaceutical Manufacturing organization required. – Demonstrated experience performing batch record review and disposition, investigating product complaints and conducting deviation investigations required. – In depth knowledge of CGMPs and Regulatory Guidelines; prior experience with regulatory inspections preferred – Excellent communication skills (oral and written) – 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 a must – Strong interpersonal relationship skills; ability to work effectively and gain consensus across the organization – Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word, Excel, and Microsoft TEAMS) – Working knowledge of Trackwise desirable – Ability to work independently with minimal supervision and direction For more info on this & other exciting roles please contact me MARC LEVINE C: E: Location/Region: Baltimore,MD