ROLE SUMMARY

This position is part of a focused team whose responsibility it is to ensure products manufactured/packaged meet product and release criteria. The position is responsible for timely batch record review, evaluation and release of product, raw materials, components, and support materials, while ensuring that manufacturing operations conform to establisher standards, procedures, cGMPs and specifications. The position is responsible for identifying discrepancies and deviations through review of batch records and associated documents, as well as alerting management of any issue that may adversely impact the product(s) manufactured or in the market. This position requires regular onsite attendance and may not be time bound to core hours.

ROLE RESPONSIBILITIES

The essential functions of the position may include, but are not limited to:

• Reviews Batch Records for compliance to SOPs and determination of batch acceptability.
• Determines batch acceptability for further processing, reject or release.
• Assists in the issuance of batch records to manufacturing, stability test reports and control/archival of in-process and completed records.
• Quarantines and rejects material as needed, including PRISM Transactions.
• Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in the manufacturing and packaging operations.
• Addresses third part audit findings.
• Supports customer and regulatory audits.
• Collects/trends data, participates in M1, yellow belt, green belt projects as assigned.

Other tasks as assigned by management.

BASIC QUALIFICATIONS·

• BS in a science related discipline plus 0-2 year’s GMP manufacturing experience in a Pharmaceutical or Medical Device manufacturing GMP facility.

OR

Associate degree plus 2 year’s Manufacturing or Quality experience in a Pharmaceutical or Medical Device manufacturing GMP facility.

• Independently consistently produces quality work.
• Works in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have effective written and oral communication skills.
• Experience at a manufacturing site preferred.
• Experience in Batch record review/audit/disposition preferred.
• Knowledge of FDA and International regulations. preferred.

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.