Quality Specialist, Operations

The Quality Specialist, Operations is responsible to maintain the environmental monitoring program, participate in the Annual Product Review, participates and initiates documentation change controls, and may participate in internal audits, etc. across the commercial business. The Quality Specialist, Operations is responsible for supporting and actively participating in the day-to-day manufacturing operations during product manufacturing, incoming material and finished good/labeling operations. Examples include in-process and finished product sampling and sample submission to the analytical laboratory, component inspections, labeling issuance and area clearance to confirm process readiness, non-conforming event support to resolve in-process issues, assists in complaint handling and complaint investigations, and process validation and qualification activities. Communicates to multiple departments and supervision to provide timely process and issue updates. Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams. Participates in reviews and structured processes for continuous improvement. Trains other local and off-site personnel and participates in resolving complex issues.

All incumbents are responsible for following applicable Division & Company policies and procedures.

• Responsible for maintaining the Annual Environmental Monitoring Qualification program in conjunction with leadership
• Responsible in conducting Environmental Monitoring Excursion investigations and participate in periodic Environmental Monitoring Assessments.
• Responds to and escalates events identified as nonconformance
• Performs physical inspection of incoming, in-process and finished product samples as assigned and according to the production schedule
• Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements
• Is competent in all processes (incoming component/labeling inspection, blending/pellet/mixing/cartridge/Xerogel/primary Packaging, sterilization, Priming, and secondary packaging inspections)
• Labels in Process and finished product materials with appropriate status
• Performs GMP related verifications including area, equipment and line clearances, cleaning, room inspection, material verification, etc. according to procedures
• Performs environmental monitoring (particulate, viable air) as needed for QC/AS sampling
• Supports Environmental Monitoring program

• Evaluation of growth media, growth media sample submissions, reviews and sorts EM data sheets by lot record.
• Reconciles lab identification reports with corresponding EM data sheets.
• Performs data entry into tracking sheet and database.
• Prepares copies of EM data sheets as needed for appropriate document storage.
• Files EM data sheets by room.

• Performs temperature monitoring (as necessary)
• Inspects QA retains including purging according to retention schedule
• Actively participates in process validation and equipment qualification activities
• Participates in resolving complex issues
• Performs periodic review of quality documents and updates as necessary according to approved procedures
• Perform other duties as directed

• Supports site-wide GMP training; provides training materials and/or conducts training sessions

• Supports product complaint investigations as required

• Participates or serves as lead Quality Representative on process improvement initiatives
• Participates in gap analysis and recommends revisions to SOPs

• Collaborates with cross functional partners to identify and implement improvements

• Provides site personnel assistance with creating GMP documents according to approved templates/procedures and managing the change control approval cycle (as an initiator) using the electronic management system
• Reviews charts, logs, logbooks for compliance

• Authors deviation/investigation reports for incidents which occur in area of responsibility
• Participates in resolving complex issues and helps drive root cause determination
• Tracks and provides metrics to management for areas of responsibility; notes trends and escalates to management
• Performs other duties as directed

• Supports cross-functional and/or multi-site projects such as software evaluation, process presentations, etc.

• Performs periodic review of quality documents and updates as necessary according to approved procedures
• Trains other local and off-site personnel on procedures and QS requirements; ensures adherence to SOPs related to areas of responsibility
• Understands and stays current with regulatory guidance
• Supports site inspections/audits by providing requested documentation, acting as SME for primary job functions, and acting as scribe as needed

• Follow all procedures to ensure a safe and compliant work environment

• College degree in related field (AAS/AS/BS/BA)
• 3 years of Quality Assurance experience in the Pharmaceutical or Medical Device industry

• Solid understanding of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
• Knowledge of US and EU Regulations (ICH, EU GMPs, ISO, etc.)
• Knowledge of electronic data systems (document; inventory a plus)

• Able to communicate effectively with other departments, management and operational personnel
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
• Ability to learn new skills and monitor performance for adherence to company procedures and policies
• Detail oriented, able to work independently and work well in a team environment
• Excellent proof-reading skills; ability to identify errors
• Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs) and procedures
• Ability to use measuring equipment, i.e. balance, calipers, pipette
• Demonstrated proficiency in the use Microsoft Office software (Word, Excel, PowerPoint, Access); Project and Visio a plus
• Possess writing skills (grammar, spelling, organization of thought) and apply to standard communication and technical writing (investigations, etc.)
• Good follow up skills to ensure task completion
• Ability to travel if needed, possibly on short notice

• Lift and/or move up to 25lbs.
• Walk across plant/warehouse
• Wear appropriate gowning as required
• Ability to read for extended periods of time
• Must have good vision (with or without correction) and be free of color blindness