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
View more
- Discipline
- Manufacturing & Production, Facilities & Site, Materials/Inventory Control, Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
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 UsOur 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
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert