Senior Associate, Quality Assurance

Responsible for performing quality assurance activities that support GMP production activities.  The focus of the role is primarily technical document review and approval activities; however additional activities will be assigned based on the Senior Associate’s skill level.

Responsibilities

• Review batch records, executed aseptic process simulation forms, QC test data, and environmental monitoring reports.  Review validation data, equipment identification forms, calibration specification sheets, and equipment change forms. Communicate required changes for specific projects and help establish norms and standards.
• Review SOPs, Protocols, and Reports. 
• Release of GMP materials and supplies which will include identification of issues/concerns with raw materials and communication of problems to management.  May participate in resolution of material issues.
• Create labels using CodeSoft and manage label templates for QA and Materials Management.
• Administration of the GMP material part number system and Part Number list.
• Create or revise new Item Specifications under the supervision of management.
• Assign lot numbers and issue/reconcile batch production records.
• Generate and/or approve product labels.
• Issue and retire laboratory and equipment logs.
• Maintain the QA Archive.
• Assist with other administrative tasks as needed.
• Track and trend data and provide reports to management, as required.
• Provide support in the preparation for, conduct of, and follow-up activities associated with inspections or regulatory/accrediting agencies.
• Accompany visitors to access controlled areas as required.
• Participate in interdepartmental project teams as required.
• Support supplier qualification activities, as required.
• Serve as a backup for the document control function.
• Support supplier qualification activities, as required.
• Train R&D personnel on QA controlled documents.
• Perform or support quality related activities, as assigned.

Skills and Experience

·  Ability to work in a fast paced team environment with minimal supervision

• Proficiency in Microsoft Word and Excel
• Knowledge of Access and Visio is preferred
• Excellent written and verbal communication skills
• Excellent organizational skills and attention to detail
• Ability to deal with a variety of variables and situations 
• Ability to interpret a variety of instructions furnished in written, oral, or diagram form
• Must be knowledgeable of cGMP regulations, especially 21CFR211.
• Must be able to effectively read, write, and converse in English.
• Must have the following personal attributes: personal accountability, work ethic, sound judgment, eagerness to learn and continuously improve, and a dedication to quality.
• Must have respect for individuals and the diverse contributions of all.

Education

• B.S. required; science or related field preferred.
• 6 years of experience in pharmaceutical, biopharmaceutical, or other regulated industry.

Working Environment

·    The position is primarily a desk job in an office area.  However, secondary areas may have moderate noise levels from instruments and/or equipment. 

Physical Demands

·    Must be able to work at a computer for several hours at a time.

• May occasionally be required to lift or carry items weighing approximately up to 25 lbs.

·    Must be able to walk around facility.  Regularly required to sit, stand, walk, reach with arms, climb, balance, stoop, kneel, and crouch.

Note:  This description is not intended to be all-inclusive or a limitation of the duties of the Job.  It is intended to describe the general nature of the job which may include other duties as assumed or assigned.