Johnson & Johnson Careers
Quality Control Laboratory, Manager Technical Writing
Raritan, New Jersey; Titusville, New Jersey
Requisition ID: 9801190321
Janssen Supply Group, LLC is recruiting for a Quality Control Laboratory, Manager Technical Writing to be located in either Titusville, NJ or Raritan, New Jersey.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
This position is in the Stability Operations Laboratory and reports to the Sr. Manager - Lab Stability.
• In this exciting role, you will manage and lead a team comprising of Technical Writers and Process Specialist.
• You will take full responsibility for driving results in fast-paced multi-faceted environment by providing your expertise for all technical writings related to the Lab – such as SOPs, CAPAs, Change Controls, Work Instructions or any other GMP documentation.
• Ensure the Lab employees are fully trained meeting all GMP, Compliance and Safety requirements.
• Oversee and support the authoring of investigations (OOS, OOT, invalid assays, other laboratory related non-conformances), to evaluate the impact of the occurrence, risk to future processes, root cause analysis, CAPA determination and effectiveness within the established timelines.
• Lead investigations using root cause analysis tools and methodologies – for example - Kepner-Tregoe, Ishikawa (Fishbone Diagram), 5 Whys, etc. to determine product impact and identify root cause.
• Ensure Documentation Updates (procedures, work instructions, technical documents) in an electronic management system including management of the documentation process.
• Responsible for the development and continuous improvement of the Non-conformance NC/CAPA policies, procedures, tools and guidelines.
• Collaborate with the lab management team including QA, for quick resolution of the Investigations. Present Investigations Metrics and remediations strategies to the Leadership team on an ongoing basis.
• J&J Quality organization is continuously evolving and embracing new technologies and procedures, and it would be your job to proactively make updates to local and global SOPs, take appropriate steps for approval and train the Lab personnel with updated SOPs.
• You will be responsible with the support of your team for all lab related Change Controls related to the testing Lab which would involve collaborating with the Lab employees to initiate the Change control, documentation, lead the CC initiative and take it to the completion.
• Support lab during internal and external inspections
• Role model and support Credo based culture
• BS degree in life science field required. Degree focus/concentration in Chemistry is highly preferred. Advanced degree highly preferred.
• Minimum of 6 years' overall experience in Pharmaceutical industry required.
• Minimum of 5 years experience working as an analytical chemist in a regulated laboratory environment required.
• Experience with technical writing related to the QC Lab (investigations, SOP, CAPA, Change Control, etc.) highly preferred.
• Demonstrated use of root cause analysis tools such as Six Sigma, KT, Fishbone, 5-Why, etc. desirable.
• Knowledge of cGMP, Health Authority guidelines and regulations (FDA, EMA, Health Canada, ICH, etc.) required.
• Previous leadership experience in managing a team successfully highly preferred.
• Experience with Quality Systems such as TrackWise, DocSpace, TruVault or equivalent preferred.
• Experience with Microsoft Office applications such as Word, Excel, PowerPoint, and SharePoint required.
• Outstanding written, verbal and interpersonal communication skills with strong attention to details is a must.
• Ability to influence and drive change management in a matrixed organization required.
• This position could be either based in Titusville or Raritan, New Jersey with regular travel to the other site.
• As this position will have responsibilities at both sites. Candidate must be willing and able to travel ~50% between Raritan, NJ & Titusville, NJ sites.
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 based on disability.
United States-New Jersey-Raritan-1000 US HIghway 202
United States-New Jersey-Titusville
JANSSEN SUPPLY GROUP, LLC (6046)