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Sr QAO Specialist

Hours for this position are 6PM - 6AM

Overview

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 executing continuous improvement activities on the production floor to ensure compliance to cGMPs. Responsible for performing releases for production batch records. Technically sound over area of responsibility.

Responsibilities

+ 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.

+ Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions.

+ Responsible for contact with other CSL sites when necessary for investigations and/or changes.

+ On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide sound quality decisions of potential impact to product.

+ Execute training/awareness related to GMP changes to production personnel.

+ Participate in regulatory inspections as requested by management.

+ Responsible for authoring and/or assisting with the Annual Product Quality Reports (APQR).

+ Responsible for conducting facility walk throughs of respective coverage area and drive continuous improvement on production floor to ensure compliance to cGMPs. Partnering with department manager/supervisors to ensure compliance of areas.

+ Delegation duties for QAO Manager when necessary.

+ Responsible for providing quality support for projects relative to area of responsibility.

+ As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.

+ As appropriate to area of responsibility, perform departmental intermediate approvals.

+ Maintain a status for departmental training requirements and provide training to departmental personnel.

Qualifications

Education:

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

Experience:

• 3+ years' GMP experience working in a cGMP regulated environment such as the field of quality, manufacturing, or engineering field, applying cGMP rules in everyday activities. Knowledge of governing regulations.

_The expected base salary range for this position at hiring is $62,000 - $86,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity._

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

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

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 (https://www.cslbehring.com/our-company) .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging (https://www.csl.com/careers/inclusion-and-belonging) at CSL.

Do work that matters at CSL Behring!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement