QA Associate II

Johnson & Johnson•Malvern, PA

2d•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Quality Assurance Associate II. This position will be located in Malvern, PA. 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! On this team, we provide end-to-end quality oversight of GMP clinical supply laboratories responsible for analytical and microbiologic testing of clinical products in the biotherapeutics and advanced therapy product portfolios. 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 with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.
At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
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.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Working knowledge of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies.

Nice To Haves

Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories.
Working knowledge of cGXP regulations.
Working knowledge of Phase Appropriate GMP practices.
Knowledge of ATMP regulations and Good Tissue Practices
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

Provides Quality review/approvals and guidance associated with investigations (non-conformances), change controls, protocols, reports, SOPs, area releases, project planning and site procedures.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Partner with key stakeholders including QC, QA Operations, AD, to support analytical method qualification, validation, and method transfer to facilitate analysis of pre-clinical, clinical, and commercial products as needed.
Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment.
Support 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.
Perform regularly scheduled oversight of QC laboratories.
Coordinates, maintains, reports and drives metrics.
Acts as SME for Quality-focused systems/projects.
Provides training for Quality concepts or systems.
Monitors non-conformance and commitment data for trends.
Proactively evaluates and facilitates remediation of compliance risks.
Provides Quality/Compliance guidance and recommendations to site personnel.
Participates in quality audits, Inspection activities and responses.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EMA, EPA, and OSHA.
Other duties may be assigned as necessary.