Validation Reviewer Jobs (NOW HIRING)

Qualifications:
• BA/BS Degree in Chemistry, Engineering or a relevant field and 8 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification
OR
• MA/MS Degree in Chemistry, Engineering or a relevant field and 6 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification
OR
• PhD in Chemistry, Engineering or a relevant field and 4 years of related work experience in validation/quality related discipline or drug development with emphasis in equipment qualification
Required Skill Sets:
Technical Writing
Critical Thinking
Responsibilities:
• Provide quality review and approval of validation activities associated with changes to existing systems and projects that support the site
• Participate in protocol development and approval, investigations for deviations and champion local, corporate, and regulatory standards
• Present and support validation concepts and approaches with audits and inspections
• With limited oversight, author IQ, OQ, and PQ protocols for Quality Validation.
• Perform Quality Validation review and approval through the preparation, execution, data analysis for IQ, OQ and PQ protocols
• Perform Quality review and approval of Change Requests (CR's) related to project validation and other validation activities for the site
• Perform compliance and technical reviews/approvals of protocols and protocol data
• Review and approve validation failure investigations and non-conformities utilizing root cause analysis techniques
• Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes and the validation
• Identify process improvements before equipment, systems or processes are placed under change control during validation
• Manage and complete each assigned Annual Product Review (APR). This includes cooperating transversally with various departments and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures
• Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, as well as applicable project teams
• Track all validation documentation throughout the plant and follow-up as needed
• Exhibit safety awareness and safe work practices
Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
Broughton
Branch Phone:
(909) 244-1777
Location:
Ontario, CA