QC Technical Expert Microbiology

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. Learn more at https://www.jnj.com

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