job summary: Quality Associate I Job Summary
Successfully perform all primary activities which include providing daily quality assurance to operations, review and release of batch records and associated documents within the manufacturing facility and participate and support internal and external audits.
Assure compliance with GMP, GDDP, GLP, and company procedures. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and the client's Quality practices.
Review and release batch records and associated documents against procedures for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
Good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and the client's Quality Systems, and serve as a plant resource for compliance to these requirements.
location: Los Angeles, California
job type: Contract
salary: $25.69 - 30.22 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Partner with shift manufacturing to ensure sound quality decisions are made.
- Provide oversight to ensure a GMP area is maintained for the Building 5 area on shift.
- Obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standards, procedures and regulatory requirements.
- Performs initial investigations and reviews Events, CAPAs, and User Interventions.
- Identify areas for improvements to mitigate recurring non-conformances and drive continuous improvement.
- Review and release batch records and associated documents against Standard Operating Procedure (SOPs) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines, etc.
- Develop, lead and execute project(s) as assigned by management.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
- Assist in external and internal audits by collecting and reviewing documents as assigned by management.
- Provide guidance to members of other departments with regards to critical step verification.
- Support activities for another section or department as assigned by management.
qualifications: Education & Qualifications
- Bachelor's degree in science or other related technical field strongly preferred. Some related work experience.
- Have strong interpersonal skills
- Have the ability to operate in a dynamic, cross-functional environment.
- Be able to have great attention to detail is necessary.
- Be able to handle multiple tasks and projects concurrently
- Have strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Have good critical thinking and problem solving skills
- Have good verbal and written communication skills.
- Have general knowledge of biotech manufacturing theories and processes.
- Have knowledge of FDA and EMA Regulations, Application of Good Data & Documentation Practices (GDDP), and application of current Good Manufacturing Practices (cGMP).
- Be able to generate spreadsheets and power point presentations on the computer.
- Be able to support departmental / plant goals.
- Be able to work independently and with intermittent supervision.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
skills: Quality control, SOP, CAPA, GLP (Good Laboratory Practice), 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.