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Analyst 1 Quality Control Stability Laboratory (1 of 2) - 2406198527W

Description

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst I, Quality Control - Stability Lab ! This position will be located in Raritan, NJ.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The Analyst I is responsible for conducting stability testing in accordance with applicable procedures, standards, and GMP regulations in a safe work environment. They may also be responsible for the support of process improvements, new technologies, automated quality systems, and the transfer of new methods.

Key Responsibilities:

• Conduct general analytical testing of stability samples submitted to the QC laboratories on an as-needed basis.

• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as needed.

• Review statistical analysis, data trending, and reporting.

• Contribute to improvements or support quality & compliance and/or process improvement projects related to Stability Operations

• Responsible for initiating Quality Issues for OOS / OOT stability issues, engaging with J&J Lead Statistical SMEs for statistical support of lab investigations and test plans, where required.

• Complete and approve corrective and preventative actions (CAPA) as assigned, as well as independently execute and lead change control process.

• Participate in internal / external audits and interact with Health Authorities during inspections and lead in discussions demonstrating a proficiency of lab systems, products, and technologies.

Qualifications

Education:

A Minimum of a Bachelor’s Degree is required with a focus in Biology, Biochemistry, Microbiology, Chemistry or related scientific field is preferred.

Required:

• 6 months to 2 years of relevant experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry

• Basic knowledge of cGMP compliance relevant to a QC laboratory work environment

• Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC

• Basic technical writing skills

• Proficiency with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)

• Excellent written and verbal communication skills, with demonstrated ability to work cross-functionally

Preferred:

• Understanding and knowledge of current Good Manufacturing Practices (cGMP) or Good Laboratory Practices (cGLP)

• Knowledge of analytical techniques such as UPLC, HPLC, Dissolution, TOC, or pH meters

• Work experience with electronic Laboratory Inventory Management Systems (eLIMS)

• Technical writing experience (e.g., SOPs, Work instructions, TMD, Protocol/Validation reports) and the ability to read/interpret technical documents.

• Experience, training, or certification with Process Excellence tools and methodologies.

Other:

• Requires up to 10% domestic travel.

• Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing.

• This position has an estimated annual salary of 50,000- 90,000 USD$

• • - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

• Holiday pay, including Floating Holidays – up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

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 NA-US-New Jersey-Raritan

Organization JANSSEN SUPPLY GROUP, LLC (6046)

Travel Yes, 10 % of the Time

Job Function Quality Control

Req ID: 2406198527W