Proclinical is seeking a Senior Quality Assurance Associate for a permanent role based in Bristol, PA.
Primary Responsibilities:
This role focuses on ensuring the site's adherence to audit findings and leading corrective action plans. The successful candidate will also host and support client audits, manage responses to observations, and oversee the creation, review, and approval of various Quality and Regulatory records.
Skills & Requirements:
- Strong understanding of audit processes and corrective action plans.
- Experience in hosting and supporting client audits.
- Ability to manage responses to audit observations and ensure timely closure of assigned actions.
- Proficiency in creating, reviewing, and approving various Quality and Regulatory records.
- Experience in overseeing training programs and providing cGMP training.
The Senior Quality Assurance Associate's responsibilities will be:
- Provide guidance to support the site in addressing audit findings and lead corrective action plans.
- Host and support client audits, ensuring the site is prepared and managing the audit while the client is onsite.
- Manage responses to observations received during client audits, ensuring timely 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 on an annual basis.
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at (+1) or .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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