Johnson & Johnson Careers

Quality Control Specialist

Malvern, Pennsylvania
Quality Control


Job Description

Requisition ID: 7339190211

Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need. Janssen Supply Group is currently recruiting for a Quality Control Specialist in Malvern, PA and Spring House, PA

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion.

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.

The Quality Control Specialist supporting the QC organization is responsible for document management, quality records, data trending, management review recording, training administration and reference standard quality support.

Responsibilities:

• Performs all QC investigations (events, deviations, invalid assays)
• Performs Gap Assessments for local QC documents against new standards and other quality documents
• Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified
• Owns change controls specific to Quality Control changes
• 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 oversight of QC reference standards
• Acts as QC point of contact for local organization training needs
• Maintain 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

Qualifications
• Minimum of a Bachelor’s degree is required
• Minimum of 2-4 years of relevant experience is required
• Skilled in all 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
• Proficient in performing technical writing is required
• Ability to independently perform project management functions is required
• Basic knowledge of Johnson & Johnson Quality and Compliance standards is required
• Detailed knowledge and experience in applying statistical concepts to laboratory data is required
• Experience developing and setting long-term objectives is required
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required
• This position is located in Malvern, PA and Spring House, PA and may require up to 10% travel

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.


Primary Location
United States-Pennsylvania-Malvern-
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
7339190211