2 Jobs
Abzena is Hiring a Senior QA Associate Near Bristol, PA
Responsibilities
- Conduct internal and external audits to ensure adherence to Azena Quality standards, industry best practice and global Regulatory compliance.
- Provide guidance to support the site with addressing any audit findings and lead corrective action plans.
- Host and support client audits to ensure the site is prepared for the audit and manage the audit while client is onsite.
- Manage responses to observations received during client audits and ensure on time responses and closure of assigned actions
- Oversee the creation, review, and approval of SOPs, protocols, reports, validation documents and other Quality and Regulatory records for accuracy and conformance with industry best practices and global Regulatory requirements.
- Oversee the training program and provide cGMP training to new hires and annually.
- Leads continuous improvement efforts regarding the Quality Systems and procedures while independently identifying areas for improvement.
- Maintains the Supplier Quality Management Program to ensure all audits are scheduled appropriately and questionnaires are completed in a timely manner. Additionally, working cross functionally to maintain and update the Approved Vendor List.
- Advises the Operations teams regarding discrepancy reports (e.g., deviations, CAPAs, complaints, etc.).
- Provides compliance advice and oversight for Abzena’s Electronic Quality Management Systems.
- Provide QA guidance to Manufacturing during processing and testing of GMP batches, analyze data and documentation to support batch disposition.
- Direct oversight of Environmental Monitoring program
- Lead projects directed towards the optimization of processes and procedures
- Provides QA review and/or approval of cGMP documents to ensure Abzena documentation and quality records are appropriately written, identified, accurate, complete, organized and readily retrievable within the system.
- Communicates effectively with supervisors, colleagues, and subordinates.
- Participates effectively as a team player in all aspects of Abzena’s business.
- Travels as needed to attend audits, professional conferences, and training opportunities.
- Remains responsible for 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.
- Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
- Operates to the highest ethical and moral standards.
- Minimum of B.S. degree in Life Sciences or related discipline with a minimum of five (5) years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
- Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial. Experience with good aseptic technique is a plus.
- Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
- Excellent communication skills, both written and verbal.
- Excellent organizational skills and attention to detail.
- Must be familiar with Microsoft Office applications.
- Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
Abzena is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identify and expression, parental status, protected veteran status, disability/handicap status, national origin, age, disability, citizenship status, marital status or any other characteristics protected by applicable laws, regulations and ordinances.
Job Summary
Full Time
Scientific Services
$109k-136k (estimate)
05/30/2024
06/19/2024
CAMBRIDGE
25 - 50
2001
JONATHAN HOWARD GOLDMAN
<$5M
Scientific Services
Related Companies
The job skills required for Senior QA Associate include Quality Assurance, Quality Management, SOP, Leadership, Microsoft Office, Continuous Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior QA Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior QA Associate. Select any job title you are interested in and start to search job requirements.
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