• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Meridian policy and cGMP's.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems
  
  Qualifications
  Must-Have
• BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering or other science related discipline
• Experience: 0-2 year's GMP pharmaceutical experience and/or Manufacturing Quality Assurance experience
• Independently consistently produces quality work
• Works in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Must work under short timelines while maintaining quality work

OR

• Associate degree in any science related discipline and 2-4 years of experience in manufacturing, quality and batch review in a pharmaceutical or medical device manufacturing GMP facility

Nice-to-Have

• Experience at a manufacturing site
• Experience in batch record review/audit/disposition
• Knowledge of FDA and International regulations

PHYSICAL/MENTAL REQUIREMENTS

Ability to multi-task, work under tight timelines and analyze complex data.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Split shift 11:00am-7:30pm Monday-Friday with potential for weekend shifts and/or 2nd shift 1:00pm-9:30pm to support production.

Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.