At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Job Title: Quality Assurance Specialist
Job Summary:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Johnson & Johnson Innovative Medicine as required by Good Manufacturing Practice (GMP).
The successful candidate will provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Responsibilities:
* Batch Record Review & Material Release: Ensure compliance with GMP requirements.
* Event Management: Carry out tasks related to administration of event management systems including review and approval of events, deviations, and customer complaints.
* Batch Records Design and Approval: Carry out tasks related to management of batch records design and approval.
* SAP Quality Management Module Administration: Carry out tasks related to administration of the SAP Quality Management Module.
* Site Change Control Systems Management: Carry out tasks relating to management of site change control systems.
* Annual Product Reviews: Compile annual product reviews.
* Validation Activities: Support all validation activities on site as described in the Site Validation Master Plan.
* Protocol and Report Approval: Approve and compile where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
* System Qualification and Process Validation: Support system qualification and process validation activities.
* SOP and Work Instruction Review: Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* GMP Inspections Preparation: Co-ordinate and assist in the preparation for regulatory and customer GMP inspections of the site.
* New Product Introduction Team Participation: Participate in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI).
* GMP Audits: Perform GMP audits on-site and vendor facilities as required.
* Supplier Approval Process Administration: Carry out tasks related to the administration of site supplier approval process.
Key Skills and Competencies:
* Excellent interpersonal skills
* Ability to operate as part of a team is critical
* Customer focus
* Innovative
* Excellent communication skills both written and verbal
* Attention to detail
* Good problem solving skills
* Results and performance driven
* Adaptable and flexible
* Decision making
Qualifications and Experience:
* Essential qualifications include a Bachelor's degree in a scientific/technical discipline and 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.