QAO Specialist I
CSL
Summary
This is an entry level position into Quality Assurance Operations. Responsibilities include real time production floor monitoring, real time review of batch records, including critical processing steps, as well as all other ancillary manufacturing and support systems documentation. Assisting with investigating deviations, relevant to area of responsibility. Responsible for supporting continuous improvement on production floor to ensure compliance to cGMPs. Works under direct supervision.
Job description
Responsibilities
- Responsible for real-time review of critical in-process steps, review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/process/equipment/documentation issues.
- Real time floor monitoring for process adherence, safety and quality issues, and reporting of any findings through the eQMS or department or Quality escalations as appropriate.
- Responsible for participating in investigation meetings with responsible department and any required support group(s) to help determine root cause, corrective/preventative actions, and product disposition.
- On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
- Execute training/awareness related to investigation and GMP changes to production personnel.
- Support continuous improvement on production floor to ensure compliance to cGMPs.
- As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.
- Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements.
- Provide awareness training on deviations to department personnel.
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 and Veeva knowledge is a plus.
Working Conditions
Onsite 100% of time
Requirements
- B.A. or B.S. degree preferably in scientific or technical field
- 0-2 years' experience working in a cGMP regulated environment
- Must demonstrate competency in verbal and written communication
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.