What are the responsibilities and job description for the QC Specialist (Microbiology) position at CSL Behring?
Job Description
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? CSL Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join CSL Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
You will report to the Team Lead, QC and work onsite at our CSL Seqirus location in Holly Springs, NC. You will provides Technical SME support in the Quality Control Department at CSL Seqirus of the relevant laboratory for Assays and Equipment, Compliance Records, Regulatory Audits, Deviation Management, CAPAs, Work Orders, Reports, Trends/Metrics and Document Creation/Revisions. Benefits Include an annual bonus, Onsite Café, walking trail and other outdoor amenities, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire.
Responsibilities
- Technical SME for all assays and equipment. Support all Analysts in the relevant laboratory with troubleshooting, assisting with equipment breakdowns, and assessing new equipment implementation.
- Help train Analysts in the laboratory as relevant laboratory assay SME.
- Be liaison between AS&T and relevant laboratory to assist with and perform method validations/verifications.
- Lead harmonization efforts with other Seqirus site relevant laboratories.
- Lead deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence and serve as QC liaison with other department investigation writers to ensure complete resolution. Employs standardized root cause analysis, investigation tools and methodologies.
- Participate in continuous improvement programs/gemba kaizen events to eliminate unnecessary activities/maximize efficiency.
- Provide support with assigned business process systems (e.g. SAP, LIMS, EDMS, LMS, TrackWise, etc.).
- Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders.
- SME input on QC Change Control Evaluation and Implementation Actions, Corrective Actions/Preventative Actions (CAPAs) and Document revision/Periodic Review workflows to support the Quality Control department.
- Complies with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
- Responsible for reviewing and analyzing trend reports to identify areas requiring additional action (e.g. quarterly reports, APQR, invalids, OOS/OOT).
- Assist in departmental metrics and key performance indicators (KPIs) by attendance through QCOLT for Senior leadership review.
- Be the relevant laboratory's technical SME during regulatory and self-inspection audits according to all cGMP regulatory (e.g. USP/EP) and Seqirus Quality Manual requirements.
Minimum Qualifications:
- Bachelor's degree and 3 years' experience or equivalent (minimum), a degree in Microbiology a plus
- Basic knowledge of cGMP and FDA requirements preferred
- Knowledge of Laboratory Systems and Investigation/Deviation/CAPA writing required
- Strong oral, written and interpersonal communication skills. Demonstrated technical writing skills.
- The ability to work effectively in both a team environment and an individual contributor role.
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Our Benefits
CSL Seqirus 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 Seqirus 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 Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus .
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35 countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
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