Hiring: Quality Systems Specialist II Company: PCI Pharma Services Location: San Diego, CA Job Posted Time: 2026-09-15 13:51:57 Employment Type: Full-time Target Skills & Keywords : Quality Assurance, Stakeholder Management About the job Required Skills: •To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned. •Independently support assigned deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities. •Review quality records for completeness, accuracy, procedural compliance, and appropriate supporting evidence. •Coordinate with Manufacturing, Quality Control, Validation, Engineering, and other functions to obtain information and progress records. •Support root-cause analysis, risk assessments, corrective-action development, and effectiveness verification. •Track assigned records against established timelines and escalate delays, risks, or resource constraints. •Support Quality KPI data collection, verification, reconciliation, and routine trend reporting. •Identify recurring issues or process inefficiencies and recommend practical improvements. Qualifications: •The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. •High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred; equivalent combination of education and/or relevant work experience will be considered. •3-5 or more years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry. •Demonstrated knowledge of GMP regulations and quality-system requirements, including applicable FDA, EU, and international regulatory expectations. •Demonstrated experience interacting with clients, regulatory agencies, and internal or external auditors. •Strong analytical, organizational, problem-solving, and decision-making skills. •Demonstrated capacity to support multiple priorities in a fast-paced, complex manufacturing environment. •Strong written, verbal, presentation, and stakeholder-management skills. •Proficiency with electronic quality management systems and quality-data reporting tools preferred. •Independent and timely support of assigned deviations, investigations, CAPAs, change controls, and quality events. Compensation: •$76,000 - $85,500 / year •Competitive benefits and rewards package •The hiring rate for this position is $76,000 - 85,500 plus eligibility for an annual performance bonus Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!