Quality Assurance Specialist (Product Complaints)
redbock an nes fircroft companyLexington, KY
Quality Assurance Specialist (Product Complaints)
L6
redbock an nes fircroft companyLexington, KYyesterday
Industries
Research and Development in BiotechnologyBiological Product ManufacturingIn-Vitro Diagnostic Substance ManufacturingLocation: San Diego preferred; fully remote candidates will be considered
Target start: Monday 11/23, potentially sooner Initial duration: Through April 20, 2027, with strong potential for further extension A fast-growing biotechnology company is seeking a QA Specialist to provide immediate support to its Product Complaints team. This consultant will replace an existing team member and will primarily support the day-to-day administration and processing of product complaints. The role is heavily focused on monitoring and triaging the complaints inbox, processing and closing complaints, following up on open items, and supporting reconciliation activities with external vendors. The team would prefer someone local to San Diego, but the position can be fully remote for a strong candidate.
Responsibilities:
- Monitor and triage the product complaints inbox daily and escalate critical complaints as appropriate
- Record, track, process, and close product complaints within the complaint management system
- Manage follow-up activities to help ensure complaints are closed in a timely manner
- Coordinate with internal teams and external vendors/CMOs regarding complaint investigations and outstanding information
- Perform complaint-related reconciliation activities with vendors
- Maintain complaint tracking logs and other assigned Quality records
- Support complaint trending and periodic metrics as needed
- Assist with audit or inspection-readiness activities as needed
Requirements:
- Bachelor's degree required
- Approximately 2-5 years of relevant QA experience within biotechnology, pharmaceutical, or medical device environments
- Previous experience supporting product complaints, complaint handling, or a closely related Quality function
- Strong attention to detail and organizational skills
- Comfortable managing routine, detail-oriented work with a high volume of follow-up and documentation
- Strong written and verbal communication skills
- Ability to work effectively with cross-functional teams and external vendors
- Experience using electronic Quality/document management systems preferred
- San Diego-area candidates preferred, but fully remote candidates will be considered
Apply now (opens in a new tab)
Level
LeadL6
Location
Lexington, KY
Occupation
Quality Control Analysts
Industry
Research and Development in Biotechnology
Posted
yesterday
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