QA Associate II
About The Position
Johnson and Johnson Innovative Medicine is recruiting for a QA Associate II. This position will be located in Malvern, PA with considerations given 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. On this team, we provide end to end quality oversight of GMP manufacturing areas. 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 and cell banking
Nice To Haves
- Experience in Quality or Manufacturing for Large Molecule Manufacturing
- Working knowledge of Phase Appropriate GMP 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
- Partner with Research & Development and Supply Chain teams to support GMP manufacture of clinical products, medias, and buffers.
- Collaborate with business partners to support new product introductions.
- Perform regularly scheduled oversight of manufacturing areas and on-call support as assigned.
- Review and approve controlled documents including standard operating procedures, work instructions, and risk assessments.
- 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.
- Perform batch record review and critical alarm review.
- 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.
- Other duties may be assigned as necessary.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401(k))
- long-term incentive program
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
