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Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Ringaskiddy, Cork, Ireland
Job Description:
POSITION SUMMARY
The candidate must have a strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry or Microbiology. The candidate must have prior supervisory experience of working in an IMB/FDA regulated facility.
The individual will be responsible for:
* Qualification of analytical equipment and related testing functions such as HPLC, Spectrophotometry, Nephelometry and Total Organic Carbon etc.
* Sampling and testing coordination during plant and laboratory utility qualification.
* Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs.
* Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.
* Implementation of Analyst Training programs. Partners with other Departments and Team Leaders to ensure that activities related to QC are completed in an efficient manner
GENERAL SCOPE OF RESPONSIBILITIES
* Supports Team leader on day to day testing operations.
* Performs Data and QC Investigations review and approval.
* Reviews Specifications and plans for associated LIMS scheduling.
* Reviews and approves deviations, CAPA's and Change Control.
* Plans and oversees lab related projects, ie., Method transfers, Equipment Qualification etc.
* Proactively identifies and drives lab process improvements.
* Trains laboratory team on specific analytical technology.
* Provides subject matter expert technical support on specific analytical technology.
* Supports lean initiatives in the area of lab operations, ie., test method execution, documentation updates and equipment qualification etc.
* Presents technical analytical clearly and concisely data to customers, internal investigations and regulatory inspectors, etc.
* Keeps abreast of analytical technology and compliance trends.
KEY COMPETENCIES REQUIRED
* Collaboration and team work
* Strategic thinker
* Problem solving and attention to detail
* Results and performance driven
* Coaching and mentoring style
* Integrity, trustworthiness and objectivity
* Customer focus
* Clear communication skills
* Adaptable and flexible
* Innovative
* Inclusive, facilitative style
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES
* Builds strong productive relationships
* 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
QUALIFICATIONS AND EXPERIENCE
* Bachelor's Degree in Chemistry or related field
* 4-6 years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience
* Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes
* Working knowledge of Quality systems
* Strong technical knowledge in and experience with QC analytical testing methods and equipment is required
* Knowledge of cGMP regulations and FDA/EU guidance is required
ESSENTIAL
* Support cGMP routine testing by owning quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
* Ensure effective planning of the data review assignments by completing data validation within data review window
* Perform data review assignments in accordance with the established laboratory procedures on data integrity and documentation
* Drive, author, and review laboratory documents, such as protocols, reports, standard operating procedure, work instructions and other quality documents as per requirement
* Operate and provide support for overall laboratory instruments/equipment as per requirement
* Lead and provide training to colleagues as SME
* Initiate change requests with applicable procedures /policies
* Escalate any non-conformances noted immediately to the supervisor/ in-charge, initiate Quality Issues identified as per applicable procedure, participate in the investigation, perform investigation analysis, and provide necessary information to enable implementation of effective CAPA
* Provide strong technical/scientific support to internal and external customers when needed.
* Develop qualification or validation methods to be used by the Quality Control unit
* Participate and lead in special projects as QC analytical technical team member
* Ensure effective capacity planning and performance management of the task assigned.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy