QA Associate II - PR
About The Position
The QA Associate II will be responsible for reviewing, approving, and releasing manufacturing, packaging, and clinical batch records, along with auxiliary documentation. This role involves preparing product release summaries and creating Certificates of Analysis/Certificates of Compliance. The associate will review laboratory test results against specifications, ensure batch releases comply with Standard Operating Procedures (SOPs), and resolve any non-conformances before release. Additionally, the position requires reporting and approving deviations, conducting Enterprise Resource Planning (ERP) transactions, attending scheduling meetings, and communicating potential delays. The role also includes assisting with investigation reports and Corrective and Preventive Actions (CAPA) within the Quality Management System (QMS), writing reports, collaborating effectively, and managing multiple priorities in a fast-paced environment while adhering to company ethics and regulatory requirements.
Requirements
- B.A. / B.S. degree and a minimum of four years of related experience or six to eight years of related experience.
- Familiarity with overall pharmaceutical manufacturing and quality systems/processes.
- Good command of the English language, both written and verbal.
- Excellent organizational skills.
- Ability to effectively manage time.
- Ability to follow instructions according to written procedures.
- Ability to manage multiple priorities in a fast-paced and changing environment.
- Operate in accordance with the company's Code of Conduct and Business Ethics.
- Adherence to all established regulatory, compliance, and safety requirements.
Responsibilities
- Review, approve, and release manufacturing, packaging, and clinical batch records along with auxiliary documentation.
- Prepare product release summaries and create Certificates of Analysis/Certificates of Compliance.
- Review and compare laboratory test results to the official specifications and prepare product release documentation/summaries.
- Ensure that batch releases are performed in accordance with current approved Standard Operating Procedures (SOPs).
- Confirm that all supporting documents are received and compliant before release.
- Resolve any non-conformances prior to release.
- Report and approve all deviations in manufacturing, packaging, and quality control per the SOPs, assessing 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.
- Communicate any potential delays in the release of materials and batches for manufacturing, R&D, or commercial distribution.
- Assist with investigation reports and Corrective and Preventive Actions (CAPA) in the Quality Management System (QMS).
- Participate in special projects as required.
- Write reports and correspondence effectively.
- Collaborate as a team member to achieve all outcomes.
- Demonstrate a good command of the English language, both written and verbal.
- Exhibit excellent organizational skills and effectively manage time.
- Follow instructions according to written procedures and manage multiple priorities in a fast-paced and changing environment.
- Operate in accordance with the company's Code of Conduct and Business Ethics, as well as all established regulatory, compliance, and safety requirements.
- Perform other duties as assigned by the manager.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
