QC Analyst IP - 2406163495W

　　Description

　　POSITION SUMMARY:

　　This position is responsible for carrying out tasks and projects related to equipment, lab

　　utilities and testing procedures at Janssen Sciences Ireland (JSI) as required by Good

　　Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC

　　testing activities are completed in an efficient manner.

　　Possibility of it being a 4-shift-cycle.

　　GENERAL SCOPE OF RESPONSIBILITIES:

　　Achieves competency in JSI laboratory methods and procedures.

　　Trains other QC analysts in laboratory methods and procedures when required.

　　Performs analytical testing activities in relation to method validation and technical

　　transfer activities so as to ensure that all methods meet ICH, CFR USP and EP

　　guidelines.

　　Executes validation, operation, maintenance, calibration and troubleshooting ofequipment and its associated software.

　　Writes, executes, reports and reviews IQ/OQ and PQ protocols so as to ensure that allrelevant equipment is qualified for cGMP use.

　　Performs routine and non-routine analytical testing activities.

　　Review and approval (where appropriate) of laboratory test results.

　　Ensures that testing and results approval are completed within agreed turnaround

　　times.

　　Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.

　　Ensures QC activities are carried out in compliance with product licence

　　commitments, cGMP and company quality standards.

　　Is an active member of the QC group and provide assistance with other groupactivities as required and communicates relevant issues to the QC Team Leader and

　　Manager.

　　Anticipates and plans for future requirements in the area.

　　Deals with non-conformances/ deviations in an accurate and timely manner.

　　Deputizes for the QC Team Leader as appropriate.

　　Maintains and develops knowledge of analytical technology as well as cGMP

　　standards.

　　KEY COMPETENCIES REQUIRED:

　　Facilitate an environment of continuous improvement

　　Collaboration and teamwork

　　Strategic Thinker

　　Credo value of integrity

　　To work as a strategic partner with all other departments within the company

　　Interface with all site departments as 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

　　Qualifications

　　QUALIFICATIONS AND EXPERIENCE:

　　ESSENTIAL:

　　A third level qualification in a scientific/technical discipline required.

　　A minimum of 2 years experience in a laboratory-testing environment within the

　　biological and/or pharmaceutical industry.

　　Knowledgeable of FDA/EMEA regulatory requirements applicable to biologicsand/or pharmaceuticals.

　　Demonstrated knowledge and testing experience in an FDA/IMB approved QClaboratory.

　　NOTE: A waiver may be granted in exceptional circumstances for individuals who are not

　　performing those tasks requiring the above qualifications and experience. This would be at the

　　discretion of the QC Team Leader in conjunction with QC Manager.

　　DESIRABLE:

　　N/A

　　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

　　Maintains the highest standards of ethical behaviour

　　Treats people with dignity and respect

　　Significant Environmental, Health & Safety considerations:

　　All employees are required to comply with the requirements of the company’s

　　Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures,

　　local legislation and duties outlined in the site EHS Manual.

　　In line with the Safety Health & Welfare at Work Act (2005), all employees are required

　　to:

　　Take reasonable care to protect his or her own and the safety of their colleagueswho may be affected by their actions.

　　Comply with EHS rules and procedures at all times.

　　Understand the potential EHS impact of their activities

　　Attend and participate in EHS training as required

　　Use PPE and safety equipment as required.

　　Report all incidents, accidents, and near miss events.

　　Report unsafe plant, equipment, acts, procedures or issues

　　Make suggestions to improve health and safety in the workplace.

　　Actively participate in work area EHS teams.

　　Not turn a ‘blind eye’ to unsafe acts or situations

　　IMPORTANT

　　This position description is a general guideline for colleagues; it does not purport to be an

　　exhaustive list of all elements of the position. Management reserves the right to modify

　　this position description at any time, or to vary the duties and responsibilities of the

　　position to meet production, scheduling or other business needs.

　　Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork

　　Organization Janssen R&D Ireland (7566)

　　Job Function Quality Control

　　Req ID: 2406163495W