At Microbiologics, we believe that "great vision without great people is irrelevant". That's why we are always looking for great people to join our dynamic, innovative company as we provide the highest quality biomaterials for a safer, healthier world. Our award-winning culture is friendly, collaborative and supportive - which provides endless opportunities for individuals to learn and grow, both personally and professionally. We else can we offer you? Glad you asked! Daycare assistance, tuition reimbursement, a 401k program with generous matching, bonus potential, a competitive compensation and benefits package, and plenty of opportunities for training and professional development.
We are currently looking to add a Quality Assurance Specialist to our San Diego Team. Duties include:
The Quality Assurance Specialist has authority and responsibility for maintaining and improving the quality management system at Microbiologics. Contribute and provide critical review for research, development, and compilation of specific and regulatory mandated processes for Microbiologics products. Responsible for ensuring that the laboratory carries out its testing activities in such a way that it meets all the regulatory mandated applications for ISO 13485:2016, GCLP, company policies and procedures. Assisting in all aspects of the Quality Systems department, including Document Control and change orders, as well as stand-alone projects as assigned and directed.
- Maintain and improve quality management system processes and procedures.
- Provide SME support and mentor others on QMS related issues.
- Mentor and Train employees on Document Control requirements, Change Orders and CAPA Processes.
- Apply effective problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Aid in the Change Order process, including review of change orders prior to approval and releasing documents upon approval.
- Aid in customer audits, regulatory audits, and audit responses with support.
- Assist with process and equipment validation protocols/reports with potential to aid in completing the validation
- Write procedures, validations, training qualifications and conducts other special projects as needed.
- Interacts and communicates with key Company personnel.
ISO 13485:2016 & GLP/GCLP
- Ensure that the quality system requirements are effectively established, implemented, and maintained in accordance with ISO 13485 and other regulations and standards as directed by Quality Systems Manager
- Assist in/perform CAPA investigations, root cause analysis, develop corrective actions, and verify effectiveness.
- Can serve on the Material Review Board.
- Assist with supplier assessments and supplier audits with support.
- Assist with the internal audit program by performing audits under the aid of the lead auditor.
- Assists scientists and operations in resolving difficult customer complaints.
- Help prepare Management Review slide deck: prepare NCMR, CAPA, Complaint slides. to ensure continuing suitability, adequacy, and effectiveness of the quality management system and assessing opportunities for improvement, the need for changes and to ensure customer satisfaction.
- Conduct GLP/GCLP in-process and data audits
- Write GCLP/GLP audit reports
- Provide consultation and compliance advice for the organization to ensure regulatory compliance
What makes you a good fit?
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's degree required, preferably in a science/technical field.
- Minimum 2 years previous related experience and/or training preferred.
- Experience with ISO 13485:2016 standards, preferred.
- Experience with 21 CFR Part 58 regulation, preferred
- Experience with GLP/GCLP regulations, preferred
- Experience with Auditing, report writing, technical writing, and document proofing.
- Presentation and training, experience preferred.
- Experience with process validations, equipment qualifications, IQ/OQ/PQ.
- Demonstrated ability to work effectively in a cross functional team.