What are the responsibilities and job description for the QA Associate II - Product Release position at AVEVA DRUG DELIVERY SYSTEMS INC?
Job Details
Job Location: Miramar, FL
Salary Range: $35.00 - $36.00 Hourly
Description
This is a second shift position, from 3:00 pm - 11:30 pm with weekend availability required.
Job Description
The incumbent is responsible for independently performing batch record reviews and making final disposition decisions for manufactured and packaged drug products. This role ensures that all batches meet specifications, are manufactured and packaged according to validated processes and procedures, comply with cGMPs, and meet both client and regulatory requirements.
- Review, approve, and release manufacturing, packaging, and clinical batch records, along with auxiliary documentation. Prepare product release summaries and create Certificates of Analysis/Compliance, as applicable.
- Review laboratory test results against official specifications and prepare product release documentation and summaries.
- Ensure that Aveva batch releases are performed according to current approved Standard Operating Procedures. Confirm that all supporting documents are received and compliant before release, and that any non-conformances are resolved.
- Report and approve all deviations in manufacturing, packaging, and quality control as per Standard Operating Procedures. Ensure deviation reviews assess the impact on the market release of the product.
- Conduct Enterprise Resource Planning (ERP) transactions as part of the release procedure.
- Attend scheduling meetings to coordinate material release priorities, as applicable.
- Communicate any potential delays in batch releases for manufacturing, R&D, or commercial distribution.
- Assist with investigation reports and CAPAs in the Quality Management System (QMS), and support special projects as needed.
- Write reports and correspondence as required.
- Collaborate as part of a team to achieve departmental goals.
- Demonstrate strong written and verbal communication skills in English.
- Exhibit excellent organizational and time management skills.
- Follow instructions according to written procedures.
- Manage multiple priorities in a fast-paced and dynamic environment.
- Operate in compliance with the company’s Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
- Perform other duties as assigned by the manager.
Qualifications
Education
- B.A./B.S. degree with a minimum of four to six years of related experience. Must have familiarity with pharmaceutical manufacturing processes and quality systems.
Knowledge, Skills, and Abilities
- Detail-oriented, accurate, and reliable.
- Excellent written and verbal communication skills in English.
- Proficient in Microsoft Office products (Word, Excel, Access, PowerPoint). Experience with ERP systems and QMS is a plus.
- Strong interpersonal skills with the ability to work effectively both within and across departments in a team environment.
- Capable of managing multiple priorities in a fast-paced setting.
- Experience with cGMP procedures in pharmaceutical and/or combination device manufacturing facilities.
Salary : $35 - $36
