Seeking a mid-level Quality professional with strong GMP experience to support audits, inspections, and management review activities in a fast-paced, regulated environment. This role requires critical thinking, excellent communication, and a project management mindset.
Schedule/Shift: Standard hours are Monday through Friday, 8:00 AM - 5:00 PM (1st Shift).
Overtime may be required during audits or inspections with prior approval.
Weekend work is not expected.
location: Newbury Park, California
job type: Contract
salary: $31.83 - 37.44 per hour
work hours: 9 to 5
education: High School
responsibilities:
- Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
- Supports Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
- Supports that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
- May perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, Change Control records and validations. May also support execution of these tasks.
- Supports ATO Management Review activities and metric control plan adherence
- Supports and audits and inspections preparation, planning, execution and response activities as well as facilitating compliance of compliance and regulatory requests
- Supports Continual Improvement initiatives, programs and projects
- Alerts management of quality, compliance, supply and safety risks
- Represents the quality management systems during audits and inspections
- Supports internal/external audits and inspections as part of the audit/inspection management team
- Completes required assigned training to permit execution of required tasks
- Responsible for complying with Good Manufacturing Practices and Good Documentation Practices
- This role may require presenting during audits and inspections, including to regulatory agencies (e.g., FDA, TGA), internal stakeholders, and external partners.
- Staff must be able to gown into clean areas to support inspection and preparation activities.
qualifications:
- Experience in pharmaceutical or biotech environments
- Strong understanding of GMP regulations and quality systems
- Comfortable engaging with internal stakeholders and external regulatory bodies
- Proficiency in tools such as C-Docs, Smartsheets, SharePoint, and QMS platforms
- Degree not required; competency, adaptability, and professionalism are essential
skills: Quality Assurance, 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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
