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 DESCRIPTION:

Johnson & Johnson is currently recruiting for a Analyst Quality Control, Lab Services! This position will be located in Malvern, PA.
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/.

POSITION SUMMARY:

The Analyst Quality Control Lab Services position supports the overall QC organization and is responsible for authoring nonconformance investigations and corrective and preventative action records, document management, investigation and assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and technical writing skills. This position will drive improvements within a global organizational framework.

EDUCATION:

Minimum of a bachelor’s degree is required

KEY SKILLS & CAPABILITIES:

• Minimum of 2-4 years of relevant experience or equivalent is required
• Skilled in basic and advanced analytical methodologies within the functional laboratory is required
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required
• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is preferred
• Proficiency in performing technical writing is required
• Ability to independently perform project management functions is preferred
• Basic knowledge of Johnson & Johnson Quality and Compliance standards is preferred
• Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
• Proficiency in using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required
  Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
  For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]

• Performs and documents all QC investigations (non-conformance, deviations, invalid assays)
• Authors and execute corrective and preventative action records
• Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified
• Manages change through chance control process
• May perform Gap Assessments for local QC documents against new standards and other quality documents
• Executes CAPAs when required for the Quality Control organization
• Works with compliance to provide QC input for the APR
• Reports data from QC as required for the site management review
• Maintains individual training completion in a compliant state
• May be asked to participate in audits
• Support Health Authority inspections
• Provide input to functional laboratory meetings
• Make decisions as a QC representative at cross-functional meetings
• Provide leadership and insight as a member of global project teams
• Provide QC input as a member of Quality focused projects