This job listing has expired and the position may no longer be open for hire.

Specialist I/II/III, QA (Front Line)- 4th Shift at Seqirus

Posted in Other 30+ days ago.

Location: holly springs, North Carolina





Job Description:

Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join 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.

Job Purpose:

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. Core responsibilities of this role include quality walkthroughs on the floor, GMP record review, log book review, and approvals, and real time triage of quality related issues.


  • Hours: 7:00am-7:00pm


  • Days: Saturday - Monday


  • Level will be determined by years of experience


Major Accountabilities:


  • Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility.

  • Reviews lot release documentation and facilitates compliant release process for corresponding market.

  • Responds to questions from regulatory authorities to ensure timely product release.

  • Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements.

  • Executes training/awareness related to GMP standards.

  • Ability to troubleshoot manufacturing issues that occur in real time.

Minimum Qualifications


  • Bachelors degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry.)

  • Minimum of 1year of GMP experience in pharmaceutical/biotech or other regulated industry required. 3 years preferred.

  • Knowledge of current Good Manufacturing Practices (cGMP) principles.

  • Aseptic experience in sterile environment a plus

  • Knowledge of FDA and EMA requirements.

Watch our 'On the Front Line' video to learn more about Seqirus


More jobs in holly springs, North Carolina


Thermo Fisher Scientific

BH Management Services, LLC

KinderCare Education LLC
More jobs in Other


ARM

ARM

ARM