Scope/Role/Description

The Senior Quality Assurance Specialist will be responsible for supporting a variety of activities within the Quality Department including the Quality Management System (QMS) and maintenance of active and inactive documents pertaining to the QMS and the production and testing of all Agena products.  In the QMS support area these activities include reviewing Device History Records (DHR) / Production Batch Records (PBR), QA release of product to inventory, and documenting non-conformances and deviations as they pertain to materials and production processes, and management of supplier quality activities. In the document support area these activities include ensuring the timely and accurate processing of Change Orders (COs). 

Tasks and Responsibilities

• Perform final document and data review for raw materials via incoming inspection documentation, and for intermediate and finished bulk via DHR or PBR review
• Participation in the Material Review Board (MRB) meetings and assist in processing Non-Conforming Material Reports (NCMR) and Return Material Authorization (RMA), including generating reports and scheduling MRB meetings
• Oversight of quarantine and status labeling of materials by coordinating with Materials Management. Coordinates/implements process flow of non-conforming materials from submission to MRB, investigation to final disposition
• Lead supplier quality activities with focus on performing supplier qualification, reviews, management of supplier files, and supplier corrective actions (SCARs)
• Participation in training programs to facilitate the proper use and implementation of quality systems
• Assisting with DHR/PBR archiving, including scanning and filing
• Assisting with the activities related to providing required documentation and implementing related documentation systems and / or processes.
• Ensures orderly storage and expedient retrieval of all documentation according to Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP) regulations.
• Incorporates changes within documents as well as coordinate reviews and approvals of documents with appropriate departments.
• Assisting with maintaining all active and inactive documents pertaining to the QMS and the production and testing of Agena products.
• Carries out duties in compliance with established business policies
• Other duties as required

Required skills and experience

Skills

• Completes specialized tasks that frequently require the exchange of detailed technical or sensitive information; establishes protocols and procedures.
• Applies specialized expertise.
• Applies job skills and company policies and procedures to complete a wide range of difficult tasks.
• Applies basic principles, theories and concepts.
• Possesses considerable knowledge of the job and several years of experience.
• Completely understands the general aspects and technical phases of the job and their practical application to problems and situations ordinarily encountered.
• Strong knowledge and skill with using MS office applications including Outlook, Excel, and PowerPoint
• Ability to create and maintain trend charts supporting, monitoring, and measuring activities
• Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred
• Knowledge of MasterControl or similar Electronic Document Database System (EDMs) preferred.
• Netsuite or similar Enterprise Resource Planning (ERP) system knowledge preferred
• Knowledge of using professional concepts and company's policies and procedures to solve a variety of problems; works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors; exercises judgment within defined procedures and practices; normally receives general instructions on routine work, detailed instructions on new assignments

Problem Solving

• Uses judgment to identify when deviation from standard practice is required.
• Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
• Investigates alternatives within known parameters. May recommend course of action. 

Independence

• Works independently, guided by short-term objectives
• May determine methods and procedures on new assignments and may provide guidance to other nonexempt personnel.
• Supervision is minimal and work may be done without established procedures.
• Work requires evaluation and discretion within defined standards.

Interactions

• Provides guidance and serves as a technical resource to others.
• Interacts daily with peers, subordinates and functional peer groups.
• Demonstrates tact and diplomacy and uses discretion in handling sensitive matters.
• Communicates effectively with internal and external personnel.
• Interacts and collaborates with members of other departments to meet project objectives.
• Effectively presents in one-on-one and small group situations.

Impact

• Failure to achieve results may cause some delays in project schedules and result in allocation of additional resources.

Leadership

• Support team efforts and decisions.
• Builds consensus when necessary.

Experience

• Associate degree in Life Science or Engineering; Bachelor’s Degree preferred
• At least 1 to 2 years’ experience in a regulated medical device, in vitro diagnostic device, or pharma industry
• Certified Quality Technician CQT preferred
• Strong knowledge and skill with using MS office applications including Outlook, Excel, and PowerPoint
• Ability to create and maintain trend charts supporting, monitoring, and measuring activities
• Knowledge of GxP requirements such as Good Documentation Practice (GDP) and FDA Quality System Regulations (QSR) preferred
• Knowledge of MasterControl or similar Electronic Document Database System (EDMs) preferred.
• Netsuite or similar Enterprise Resource Planning (ERP) system knowledge preferred
• Knowledge of using professional concepts and company's policies and procedures to solve a variety of problems; works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors; exercises judgment within defined procedures and practices; normally receives general instructions on routine work, detailed instructions on new assignments

Physical Demands & Environmental Conditions

• Regularly walks, stands, and sits
• Regularly works on a computer for approximately 8 hours a day
• The position will work in a team environment, interacting with all related cross functional groups throughout the organization, including executive management, manufacturing operations, research and development, business development and marketing, finance, legal, and external consultants where applicable.
• Ability to travel to other locations as needed

Agena Bioscience, Inc. is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.