Job Summary:

The incumbent is responsible for independently performing batch record review and final disposition of manufactured and packaged drug products. This role ensures that all batches meet specification, are manufactured/packaged in accordance with validated processes and procedures, are in compliance with cGMPs, meet client requirements and regulatory requirements.

Job Responsibilities:

• Review, approve and release manufacturing, packaging and clinical batch records and auxiliary documentation, prepare product release summaries, and create Certificate of Analysis/Certificate of Compliance, as applicable
• Review and compare laboratory test results to the official specification, prepare product release documentation/summaries
• Accountable for ensuring that Aveva batch release is performed in accordance with current approved Standard Operating Procedure, and that all supporting documents are received and compliant to enable batch release and any non-conformances are resolved prior to release
• All deviations in manufacturing, packaging, quality control are reported and approved as per the Standard Operating Procedures. Ensure the review of deviations assesses the impact on the market release of product
• Conduct Enterprise Resource Planning (ERP) transactions as part of the release procedure
• Attend scheduling meeting to coordinate material release priorities as applicable.
• Communicate any potential delays in release of batches for manufacturing, R&D or commercial distribution
• Assist with investigations reports and CAPA in the Quality Management System (QMS) and special projects as required
• Ability to write reports, and correspondence
• Works as a member of a team to achieve all outcomes
• Good command of the English language (both written and verbal)
• Excellent organizational skills and the ability to manage time effectively
• Ability to follow instructions according to written procedures
• Good command of the English language (both written and verbal)
• Excellent organizational skills and the ability to manage time effectively
• Ability to follow instructions according to written procedures
• Ability to manage multiple priorities in a fast-paced and changing environment
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Other duties as assigned by the manager.

Education

B.A. /B.S. degree and minimum four to six years related experience. Must be familiar with overall pharmaceutical manufacturing and quality systems/process.

Knowledge, Skills and Abilities

• Must be detail oriented, accurate and reliable.
• Excellent written and verbal English communication skills.
• Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience using ERP system and QMS is a plus
• Superior interpersonal skills and ability to work effectively in a team environment within and outside the department
• Ability to manage multiple priorities in a fast-paced environment
• Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years
• 4 years

Schedule:

• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Miramar, FL 33025: Relocate before starting work (Required)

Work Location: In person