QA Associate II

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:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a QA Associate II to be based in Malvern, PA.

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 (

Purpose: In this role, you will be providing quality oversight of R&D GxP laboratories, Raw Material Release, and the Clinical Supply Chain warehouse responsible for analytical testing of clinical products, Raw Material handling/release, and Cell Bank CofA approvals for the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

You will be responsible for:

• Partner with R&D GxP laboratories, Cell Banking, Warehouse (clinical supply) to support analytical method transfers, clinical product and raw material release activities.

• Partner with R&D GxP/GMP teams to support process development studies.

• Perform regularly scheduled oversight of the R&D GxP laboratories and Warehouse.

• Review paper and electronic laboratory documentation for completeness and accuracy.

• Review critical alarms for appropriate response actions.

• Review and approve certificates of analysis where required.

• Author and revise quality departmental documents.

• Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.

• Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.

• Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.

• Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.

• Provide quality oversight for sample management activities.

• Participate in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.

• Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts.

• Other duties may be assigned as necessary.

Qualifications/Requirements:

• A minimum of a Bachelor's Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.

• At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.

• Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.

• Working Knowledge of cGMP regulations and FDA/EU guidance is required.

• Experience with Quality document reviews and regulatory inspection processes is preferred.

• Ability to maintain written records of work performed in paper-based and computerized quality systems is required.

• Ability to work independently on routine tasks and require some supervision on complex issues.

• Ability to be organized and capable of working in a team environment with a positive demeanor is required.

• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills are required.

• This position is located primarily in Malvern, PA and will require up to 15% local travel to Spring House, PA.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills: