Senior Quality Assurance Associate Investigations
3 days ago
We are a fully integrated contract development and manufacturing organization with a mission to help improve the health of humankind. Our comprehensive development, cGMP manufacturing, and aseptic fill finish services are provided from our sites in Belgium, United States, Japan, and India.
Our CultureWe pride ourselves in offering a unique environment where the work we do every day plays a crucial role in society. We strive to inspire employees to come to work engaged and ready to give their all, allowing us to meet the commitments we make to partners, patients, and employees.
Total Rewards PackageWe offer a Total Rewards package designed to make your life better, including:
- Health benefits
- Annual performance bonus
- Generous paid time off
- Paid parental leave
- Matching 401k contributions (immediate vesting)
- Tuition reimbursement
- Employee discount program
We are currently seeking a Sr. QA Associate I who is a Quality Subject Matter Expert. The successful candidate will ensure manufacturing areas are maintained in strict compliance, independently review and approve lot file documentation, identify and assess regulatory and quality risks in manufacturing activities and processes, and drive process improvements and enhancements.
ResponsibilitiesThe successful candidate will be responsible for:
- Identifying, investigating, resolving, and preventing compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
- Independently reviewing and approving production batch records and associated data for product release and determining if records are within range of cGMP regulations and good documentation practices
- Independently performing quality operations within multiple manufacturing departments
- Participating in multiple process improvement projects
- Developing, revising, reviewing, and approving controlled documents, including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols, and tech transfer forms
- Reviewing and approving executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product
- Representing QA for high-profile clients
- Providing quality oversight of quality reports, including deviations, corrective and preventive actions (CAPAs), and risk management plan (RMP)
- Providing quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
- Supporting the Facility/Equipment/Process Change Control System, including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
- Ensuring completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
- Exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
- Embodying Aji Bio-Pharma's cultural values and aligning daily actions with department goals and company culture
The successful candidate will have:
- A high school diploma or equivalent required; a Bachelor's degree preferred in a Life Sciences discipline or equivalent relevant experience required
- A minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
- A working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
- Knowledge of Fill Finish and Biologics production environments preferred
- Familiarity working with electronic batch records
- Detail-oriented and strong interpersonal and verbal communication skills
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