QAO Specialist I

QAO Specialist I

This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

Responsibilities

• Responsible for assisting with investigating deviations relevant to area of responsibility. Responsible for participating in investigation meetings with responsible department and any required support groups.
• Responsible for participating in necessary research to determine root cause, corrective/preventive actions, product disposition, and using the investigation tools provided by QAO Management.
• 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.
• 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) assessments.

Education

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

Experience

• 0-2 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 is preferred.

Competencies:

• Informing – is timely and accurate with information.

• Peer Relationships – Can quickly find common ground and solve problems for the good of all, is a team player and cooperative.

• Self-Knowledge – Seeks feedback, gains insights from mistakes, is open to criticism.

• Action Oriented - Enjoys working hard; is energetic for the things that he/she sees as challenging.

• Written Communications – is able to write clearly in a variety of communication settings and styles, can get messages across

• Conflict Management – Steps up to conflicts, seeing them as opportunities, can find common ground.

• Learning on the Fly – Open to change, learns quickly when facing new problems, versatile learner.

• Dealing with Ambiguity – Can effectively cope with change, can shift gears comfortably, can comfortably handle risk and ambiguity.

• Must demonstrate competency in verbal and written communication. TrackWise knowledge a plus.

• The expected wage range for this position at hiring is $23.56/hour - $30.29/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.

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

• About CSL Behring

• CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

• CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

• To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

• Our Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

• You Belong at CSL

• At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

• To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

• Equal Opportunity Employer

• CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Location

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