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FLQA Specialist I/II; 4th Shift (Days - Sat-Mon) 12 hour shifts

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Nov 17, 2022

Job Details

Job Description

The Front Line Quality Assurance (FLQA) Specialist will provide on the floor support to manufacturing (bulk, sterile formulation/filling, and packaging), laboratories, utilities, maintenance, and logistics at the Holly Springs site. Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, and real time triage of quality related issues.

The Role

This position is on 4th Shift.
Requires: working 3 days per week. Saturday, Sunday and Monday
Hours:  6:45am – 7:00pm
Must be flexible to shift schedule to support the business
Candidates may be considered at I/Il level depending on experience

QA oversight of manufacturing processes, QC laboratories, and in-process sampling


QA oversight of control, quality systems, and QA compliance.


Review of standard operating procedures (SOPs), batch production records


Use of computerized systems: SAP, CMMS, TrackWise, GLIMS, Delta V, and BAS.


Utilize knowledge of root cause analysis and risk based decision-making throughout.


Collaborate with cross-functional teams while participating on projects.


Quality review of manufacturing, QC, warehouse, utilities, and facilities


Review/approve BPRs’, Log books, protocols and SOP’s, ETP’s (Engineering Test Plans).


Responsible for knowledge of current local and international regulatory requirements.

Provide advice and appropriate technical support on all quality/compliance matters.

Your skills and experience

Bachelor’s degree in Science/ Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry

Minimum 1+ year of experience; prefer 3+ years previous experience on the floor or supporting Bulk, Fill Finish, and/or Packaging pharmaceutical operations with technical understanding of the production processes used in the biotechnology industry

Understanding of the quality requirements for the pharmaceutical industry

Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus 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 Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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