QA Associate III

Johnson & Johnson Innovative Medicine•Malvern, PA

About The Position

We are searching for the best talent for a QA Associate III to be based in Malvern, PA with occasional travel to Spring House, PA. 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 https://www.jnj.com/innovative-medicine Purpose: On this team, we provide end to end quality oversight of GMP R&D GxP laboratories responsible for analytical testing of commercial and clinical products in 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.

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 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Ability to work independently on complex issues with minimal supervision.
Ability to be organized and capable of working in a team environment with a positive demeanor.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Solid Understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies is required.

Nice To Haves

Experience in automated laboratory systems and warehouse/raw material sampling and receipt preferred.
Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories is preferred.
Working knowledge of GLP regulations preferred.
Experience working with CMMS Systems like SAP and Maximo, and electronic laboratory notebook systems (Biovia, eLIMS) is preferred.
Experience performing and leading quality risk assessments for business processes is preferred.
Experience with document reviews and regulatory inspection processes is preferred.
Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.

Responsibilities

Partner with Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.
Collaborate with business partners to support process development studies.
Perform regularly scheduled oversight of R&D GxP laboratories.
Review and approve raw material and critical reagent release for use across the Janssen global network.
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.
Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment
Lead 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.