Description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality ControlJob Category:
ProfessionalAll Job Posting Locations:
Ringaskiddy, Cork, IrelandJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
As a Technical Expert QC (Separations)
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, Bioassay or Microbiology.
The individual will be responsible for:
- Qualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture 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.
- Support and 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.
The responsibilities and the impact YOU will have:
- Supports Team leader on day-to-day testing operations.
- Performs Data and QC Investigations review and approval.
- 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:
• Clear communication skills. • Customer focus.
• Collaboration and teamwork. • Coaching and mentoring style.
• Strategic thinker. • Innovative.
• Problem solving and attention to detail. • Results and performance driven.
• Integrity, trustworthiness and objectivity.
• Adaptable and flexible. • Inclusive, facilitative style.
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:
- Builds strong productive relationships.
- Demonstrates ability to work with teams and individuals.
- 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.
We would love to hear from YOU, if you have the following essential requirements:
QUALIFICATIONS AND EXPERIENCE:
- Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field.
- 3-6 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 required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results.
- 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.
- Support 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:
The anticipated base pay range for this position is:
€52,400.00 - €82,915.00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
