Quality Specialist
Description:
• Education Requirements: Bachelor's degree preferred. Candidates with Associates degree considered with relevant experience.
• Experience required- 3-5years of relevant experience within quality assurance, quality control, investigation, sample management and complaint management.
Required Skills:
• Possesses a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
• Ability to perform routine assignments and develops competence by performing structured work assignments.
• Ability to use existing procedures to solve routine and standard problems.
• Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues.
• Promotes the team's effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.
• Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.
• Readily accepts performance feedback and incorporates this feedback into future performance.
• Learns to use new problem solving tools to solve issues.
• Ability to interpret Merck Quality Policies, Procedures and Guidelines for daily application.
• Developing technical writing capabilities and is able to compile straightforward investigations and procedures.
Day to day:
• Mailbox monitoring-Veeva mailbox to check the task
• Accept the asisgnment and start with the workflow
• Inspecting retention samples
• Pulling data
• Samples: Visual inspection of bottle of tablets, bottles of vaccines
This role has no exposure to blood products or human samples.
Responsibilities:
Complaints/Investigations Management:
• Supports the Complaint Management Topic ensuring all product quality complaints (PQC) are investigated within the specified timeframes and Corrective and Preventive Actions are identified when required.
• Assess whether reporting to Health Authority is required.
• Performs trending to identify any specific or recurring problems.
• Approves low and medium risks complaint investigations.
• Manage incoming mailbox (complaints)
• Destruction of aging complaint samples
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