Specialist II QA Operations

Position Purpose:

Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.

Responsible for investigating deviations. Responsible for ensuring deviation investigations are complete, accurate and drive continuous improvement on production floor to ensure compliance to cGMPs. Responsible for release of critical intermediates, relevant to area of responsibility.

• Responsible for investigating deviations, relevant to area of responsibility
• Responsible for facilitating root cause and CAPA discussion with responsible department and any required support group(s).
• Responsible for coordinating necessary research to determine root cause, corrective/preventative actions and product disposition, and utilizing investigation tools provided by QAO Management.
• Responsible for performing complete and accurate deviation investigations in accordance with site procedures/metrics while meeting DIFOT timelines
• Responsible for performing complete and accurate deviation investigations in accordance with site procedures/metrics while meeting DIFOT timelines
• Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions.
• On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
• Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.
• Execute training/awareness related to investigation and GMP changes to production personnel.
• Drive continuous improvement on production floor to ensure compliance to cGMPs.
• Responsible for area audits appropriate to area of responsibility and working with manufacturing personnel to resolve issues real-time.
• Assist in regulatory inspections as requested by manage
• As appropriate to area of responsibility, perform critical interim
• As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner.
• As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessment

Education:

• B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).

Experience:

• Two or more years’ experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities. Technical writing experience required. Or in lieu, proven ability to perform in this role will be considered.

Competencies:

• Time Management – uses time effectively and efficiently, concentrates efforts on the more important priorities.
•  Informing – provides information so accurate decisions can be made. Composure –
• Is able to work under pressure, handle tough situations and remain focused.
• Presentation Skills - is effective in a variety of formal presentation settings, can manage group process during the presentation
•  Written Communications – is able to write clearly in a variety of communication settings and styles, can get messages across.
• Decision Quality – makes good decisions based on analysis and judgment, sought out by others for advice and solutions
• Problem Solving – uses logic and methods to solve difficult problems with effective solutions
•  Creativity – comes up with new and unique ideas, easily makes connections among previously unrelated notions.

Additional Comments:

Functional/ Technical Skills; specifically, must have working knowledge of cGMPs and FDA guidelines. Knowledge of the Quality System (TrackWise) that support deviation investigations, and CAPA a plus.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

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