QA Associate II

Johnson & Johnson•Malvern, PA

20h•Onsite

About The Position

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 https://www.jnj.com/innovativemedicine/ 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.

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

Nice To Haves

Experience with quality support in clinical or GMP manufacturing or support of QC laboratories is preferred.
Experience with Quality document reviews and regulatory inspection processes is preferred.

Responsibilities

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.