Job Title:
Quality Assurance Specialist - QA Operations
Job Summary:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP).
Responsibilities:
* Batch Record Review & material release to ensure compliance with GMP requirements.
* Administer event management systems including Review & Approval of Event, Deviations, and Customer complaints.
* Manage batch records design and approval.
* Administer the SAP Quality Management Module.
* Manage site change control systems.
* Compile Annual Product Reviews.
* Support all validation activities on site as described in the Site Validation Master Plan.
* Approve and compile where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
* Support system qualification and process validation activities.
* Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* Coordinate and assist in the preparation for regulatory and customer GMP inspections of the site.
* Participate in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI).
* Perform GMP audits on-site and vendor facilities as required.
* Perform on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
* Administer the site supplier approval process.
Requirements:
* Bachelor's Degree in a scientific/technical discipline required.
* A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
* Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA, and other authorities.