If you are looking for an environment where you can make a difference, then Lumos Diagnostics is the right place for you!

Lumos is currently going through an exciting stage of global expansion, and we are looking for self-motivated individuals who want to help us get there and make a difference along the way.

Lumos Diagnostics has an immediate opening for a full-time Quality Assurance Analyst. to join its Quality team in Carlsbad.

Lumos Diagnostics offers a broad array of comprehensive, competitive benefit programs that add value to their employees, including medical, dental, 401k with 4% employer match, and paid time off.

Lumos Diagnostics is seeking a motivated, qualified individual with a proven track record of success and professional growth to join our dynamic team.

The Lumos Diagnostics Quality Control Analyst will support the Quality Leadership team with tasks and improvement initiatives to enhance the Quality Management System and ensure higher-quality goods. This position will be responsible for performing and supporting the Quality Control and Quality Assurance activities by ensuring that materials received, in-process product, and the final released product meets the acceptance criteria per Lumos Diagnostics’ quality system and industry standards (i.e., cGMP & ISO regulations).

The QC Analyst is responsible for performing various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. The incumbent conducts and validates various biological and chemical quality control (QC) assays. Compiles interprets and documents statistical data from testing processes to either confirm compliance with established standards or identify deviations.

Lumos is building a highly experienced team that is passionate about its role in point-of-care diagnostics. Lumos is driving to ensure they provide the best custom solutions for their partners. To learn more about Lumos Diagnostics, please visit our website at https://lumosdiagnostics.com.

POSITION RESPONSIBILITIES:

• Identify product defects or potential issues by performing incoming receiving quality inspections, in-process quality inspections, and final quality reviews and releases.
• Generate non-conformance reports for products/processes found out of specification or compliance.
• Generate relevant metrics for tracking & trending analysis.
• Support Lumos efforts to support process improvements that identify solutions to complex problems.
• Assure compliance with applicable standards and company CAPA Procedures.
• Ensure corrective actions are in place and are complying with company SOP’s.
• Develop and generate relevant Quality Objective metrics and trending analysis.
• Assist with internal audits of the Quality Management System (ISO/QSR) and ensure compliance with Internal Audits SOP’s.
• Assist with external audits, including audit preparation, documentation, follow-up, and closure. Often performs audit responses for the Carlsbad site.
• Support supplier evaluation program, including supplier audit program. Maintain supplier files and supplier monitoring. Review the program and advise Purchasing where issues exist.
• Provide technical review & support regarding revising or implementing process documentation, including procedures, work instructions, labeling requirements, and forms.
• Support and ensure the QMS complies with ISO 9001, ISO 13485, FDA Quality System Regulations (QSR), and MDSAP Requirements.
• Initiate, maintain, and review ongoing improvement projects due to periodic trend reporting; management review; complaint investigation; supplier, customer, internal audits; and any other relevant quality event. Use Six Sigma and Lean Manufacturing methodology to drive quality system improvements.
• Identify, prepare & conduct necessary training relative to maintaining an effective QMS.
• Support complaint Investigation efforts, including complaint completion and quality review before closure as needed.
• Support the Verification, Qualification & Validation activities as needed, including writing/executing protocols and scripts.
• Maintain and control applicable Product Stability Studies and assure compliance to shelf-life dating for launched products.
• Performs other related duties and tasks as assigned by Quality Management.

PREFERRED SKILLS AND QUALIFICATIONS:

• Bachelor’s degree highly preferred or equivalent/applicable experience.
• 3+ years of related experience preferred.
• Experience working in a regulated industry (GxP, cGMP, medical devices, pharmaceuticals, etc.) preferred.
• Previous experience in Quality Engineering, related manufacturing experience in Chemistry, Biotechnology, Life Science, or technical field or equivalent experience is a strong plus.
• Certified in Quality Auditing (CQA) or other Quality Certifications is a strong plus.
• Strong communication skills – verbal and written.
• Good interpersonal skills. Ability to interact and work with other employees at all levels of the organization and influence positive change.
• General knowledge of ISO 9001, ISO 13485, and other FDA Quality Regulations
• Advanced level proficiency with Word, Excel, and Internet software. Experience with Databases is highly desirable.
• Ability to rapidly shift priorities to address non-routine tasks and prioritize required functions to ensure on-time completion and manage time effectively.
• Demonstrated understanding of lab practices.

TO APPLY

If you believe your education and experience are in line with the position description and qualifications referred to above and are motivated, energetic, and looking for a new and exciting opportunity, please submit a cover letter outlining your interest in the position along with a detailed CV of your experience.

No recruitment agencies, please

Salary Range: $66,500 to $87,400

Job Type: Full-time

Pay: $66,500.00 - $87,400.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Compensation package:

• Yearly pay

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Carlsbad, CA 92010: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Quality assurance: 3 years (Required)
• Quality control: 3 years (Preferred)
• ISO 13485: 3 years (Required)
• CGMP: 3 years (Required)
• Quality systems: 3 years (Preferred)

Work Location: One location

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