job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
location: Novato, California
job type: Contract
salary: $30.60 - 36.00 per hour
work hours: 9 to 5
- Provide support and oversight for new and actively managed Supplier Change Notifications (SCNs) and supplier investigations.
- Participate, with potential to facilitate, in cross-functional Supplier Quality meetings.
- Support development of Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
- Assist in development, implementation, and enforcement of departmental policies and procedures.
- Participate in inspection preparation, train employees in focus areas and participate in regulatory inspections.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured and for Supplier related approaches utilized .
- Other duties as assigned.
qualifications: Education & Qualifications:
- BA or BS in a technical discipline (physical or biological sciences).5+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems, specifically Change Control.
- Strong ability to comprehend technical information related to raw material, process and regulatory expectations
- Proficiency with standard software applications, including MS Excel, Adobe Acrobat
- Understanding and familiarity with FDA, European, PMDA guidelines
- Exceptional organizational, spelling, grammar and typing skills.
- Effective leadership and communication skills.
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.