Role:CQA Specialist

Location:Cleveland/Akron, Ohio Area

Key Responsibilities

• Report on metrics on a regular basis as applicable.Support Doc Control, Change Control, Deviation Management, APRs, Auditing, Laboratory, Complaints, Reprocess, Recalls and Supplier Qualification.
• Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing.
• Completion of gowning qualification and maintaining status for entry into Aseptic processing area.
• Must be able to demonstrate a sound knowledge of aseptic gowning practices.
• Identify deviations and ensure the deviations are initiated according to procedure.
• Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities.Complete monthly inspections of the physical conditions of the support areas and report issues to Quality Assurance Manager.
• Ensure that current procedures are followed in connection with handling of complaints and recalls, returned goods, reprocessing and supplier specifications.
• Coordination/participation of Supplier Qualification activities as identified by the CQA Manager.
• Support of stability programs for marketed products.Participation in gathering of data needed for the Annual Product Review.
• Collecting of data for Quality Monthly Report.
• Perform additional tasks in relation to quality issues as agreed with the Quality Assurance Manager.Manage and escalate Quality issues to the Quality Assurance Manager as needed.
• Provide backup support to the MQA Specialist as needed and as approved by management.
• Work regularly under desirable conditions of the office setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
• Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
• Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform.
• Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Requirements

• B.S. in Life or Physical Science with one (1) to five (5) years equivalent education/professional experience
• Knowledge of a GMP production facility and/or inspection processes required
• Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essentialWell-organized and detailed oriented professional, with strong verbal and written communication skills
• Quality or Pharmaceutical certifications is a plus
• Physical Requirements of the RolePosition is exposed to a number of environments, office, lab, outside, plant floor, etc.

Key Skills: