QA Specialist

Quality Assurance Specialist - QA Operations X2

Location: Ringaskiddy, Cork 

Work Model: Hybrid working arrangement (3 days on-site, 2 days remote per week). 

Duration: 12 months 

Hours: 39

Imagine your next project supporting critical Quality Assurance and Good Manufacturing Practice (GMP) compliance activities at Johnson & Johnson Innovative Medicine, where you will play a key role in ensuring the quality and safety of life-changing treatments across diverse therapeutic areas.

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Johnson & Johnson Innovative Medicine (JJIM) as required by Good Manufacturing Practice (GMP). These activities include change control, nonconformance investigation, quality systems auditing, supplier qualification, documentation management, incoming materials release, batch release, annual product review and validation compliance activities at JJIM.

roles and responsibilities

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.

• Supports the development and management of GMP compliance systems through the following activities:

• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. Assesses compliance systems on an ongoing basis to identify opportunities for process improvement.

Carries out tasks related to the administration of site nonconformance management systems:

• Reviews and/or approves nonconformance investigations and their associated documentation.

• Manages entry of nonconformance records into the appropriate electronic system.

• Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.

• Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.

• Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.

Carries out tasks related to the management of site change control systems:

• Reviews and/or approves change control requests, implementation actions, and request closures.

• Manages entry of change control records into the appropriate electronic system.

• Tracks records from the initiation through closure processes and advises relevant personnel on the status of change requests and associated action items, as appropriate.

• Coordinates and chairs meetings of the site change control board. Sets meeting agenda and maintains meeting records.

• Approves closure of change requests on completion of related actions.

• Liaises with global quality systems change control representative to ensure change controls with global impact are appropriately managed.

Supports system qualification and process validation activities:

• Review and approval of qualification/validation documentation.

• Partners with QA Validation to develop and manage procedures to support qualification and validation activities.

Carries out administration of the Supplier Assessment, Auditing and Inspection Readiness Systems at the site:

• Maintains records of audits and audit communications, activities and commitments resulting from audits and inspections.

• Assists in reporting to plant management on the state of compliance at JJIM based on internal audits.

• Reviews proposed corrective actions arising from internal and supplier audits to provide assurance that deficiencies are adequately addressed.

• Tracks and monitors implementation of corrective actions to provide assurance that deficiencies have been corrected.

Supports GMP training activities:

• Partners with JJIM Training to assist in the development of training materials for provision of GMP training to site personnel.

Carries out tasks related to the administration of site supplier approval systems:

• Reviews documentation and test results, where applicable for all incoming QA released materials

• Reviews and/or approves supplier nonconformance.

• Works with logistics team to ensure all supplier and materials are qualified in accordance with GPSG SMQ process

• Develops the raw materials and components specification and co-ordinates the approval of these specifications via the global GPSG process.

• Responsible for compiling supplier data files

Carries out tasks related to the management of batch records design and release systems:

• Reviews and/or approves all completed batch records in accordance with site procedures

• Releases all batches on SAP in accordance with site procedures

• Participates in the review process for master batch records.

• Liaises with QA at fill finish sites to supply release data for JJIM FB

Supports system process support validation and process validation activities:

• Review and approval of validation documentation.

• Partners with DPDS and Validation team to develop and manage procedures to support validation activities.

Carries out administration of the SAP Quality Management Module for JJIM

• Manages the addition of new site users to the system.

• Participates in upgrade activities of the system as appropriate.

• Maintains the quality module master data and associated system procedures

• Generates reports from the system as directed by the QA Manager

Reviews and approves SOPs/work instructions/forms/validation plans from other departments on behalf of Quality Assurance.

• Deputises for the Quality Assurance or Quality Systems Manager as appropriate.

Key Individual Contributor Competencies:

• Thinks strategically to create growth

• Translates vision and strategy for direct reports and team members into actionable goals and priorities

• Takes action and makes decisions that successfully build customer value

• Works to help others to builds strong productive relationships

• Rewards direct reports and others for cultivating strong business relationships with people from other areas of the organization

• Demonstrates ability to lead teams through change or transformation

• Takes risks to drive innovation

• Directs and encourages others to achieve innovative results

• Demonstrates ability to work with teams and individuals

• Asserts personal ideas and opinions using persuasion to influence others

• Seeks opportunities to grow and develop professionally

• Uses best practices to improve business operations

• Holds self accountable for compliant and flawless execution

• Takes personal responsibility for decisions that successfully build customer value

• Effectively manages and adapts to change

• Demonstrates the courage to stand alone on ideas and opinions that differ from others

• Listens effectively and remains open to other’s ideas.

• Works effectively with people that have diverse styles, talents and ideas

• Maintains the highest standards of ethical behavior

• Treats people with dignity and respect

how to succeed

• Essential Qualifications and Experience:

• Bachelor's Degree level 8 or higher in a scientific/technical discipline required

• A minimum of 2 years experience in a quality, manufacturing, 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, HPRA, EMEA and other authorities.

Desirable Qualifications and Experience:

• Experience in auditing of external suppliers, contractors and vendors.

• Experience in development/and or evolution of GMP systems and/or start up experience highly desirable.

• Qualified Person (as qualified).

• Key Competencies Required:

• 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

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.