TriLink BioTechnologies is seeking a Quality Specialist responsible for supporting Quality Operations functions, including the review and release of batch records, review and approval of deviations, NCMRs, CAPAs, OOSs and complaints. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations. Responsibilities include:
- Responsible for reviewing and approving batch records.
- Responsible for reviewing and approving Quality Events (e.g. Deviations, NCMRs, CAPAs, OOSs, and complaints) to ensure appropriate investigations are completed timely.
- Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
- Support Raw Material release team in conducting raw material, component, in-process inspection and release in conformance to established product requirements, as needed.
- Lead cross-functional teams in risk identification and mitigation activities during risk management process.
- Review and approve Change Control requests to ensure the appropriate documentation is in place for changes in materials, equipment, processes, procedures, etc.
- Participate in the audit program, including conducting internal audits as needed. Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations. Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
- Perform other duties, as assigned.
- Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- Quality professional with a minimum of 5 years relevant experience in a life science industry.
- Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820)
- Strong and effective verbal and written communication skills.
- Strong interpersonal, teamwork and customer interfacing skills.
- Strong problem-solving skills and analytical skills applied to investigations.
- Self-motivated and able to organize and prioritize multiple tasks.
- Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
TriLink BioTechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink BioTech is an EEO Employer.