Specialist I QA Operations

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Job description

Job Description

This is an entry level position into Quality Assurance Operations. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs.

Responsibilities:
• Under general supervision, supports quality assurance processes to ensure compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines
• Performs area audits and process observation to ensure compliance and procedural adherence

• As appropriate to area of responsibility, responsible for ensuring area is maintained in a state of compliance and all area inspections are completed in a timely manner
• Coordinates and maintains documentation of manufacturing procedures, appropriate specifications, deviations, and other relevant materials

• Assures materials meet the applicable requirements following Standard Operating Procedures (SOPs)
• Follows strict cGMP guidelines in assuring material maintains the safety, identity, strength, quality, and purity

• On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation

• Identification and reporting of deviations, including collection of initial event details, supporting documentation, and relevant data and/or personnel interviews

• Collaborate with manufacturing personnel to perform initial risk assessment, determine scope of events, and identification of any required immediate actions

• Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management

• Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, investigating exceptions, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues

• Assist in batch release by performed batch record review, reviewing sample results, and confirming document release in SAP/EBR

• Execute training/awareness related to investigation and GMP changes to production personnel

• Drive continuous improvement on production floor to ensure compliance to cGMPs

Education

B.A. or B.S. degree preferred in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing); associates degree in scientific or technical field with relevant pharmaceutical industry and/or quality assurance experience

Experience

1-2 years of experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities preferred. Technical writing experience is preferred.

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

Competencies

Must demonstrate competency in verbal and written communication

Knowledge of cGMP standards

Proficiency in Microsoft Office and QA systems

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.

About Us

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Behring!