QC Technical Expert Microbiology

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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 CAPAs 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 others ideas

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

QUALIFICATIONS AND EXPERIENCE

• Bachelors 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: