Quality Systems Specialist I: Drive Compliance & Improvements

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); Hybrid; USD 70,000 - 76,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services in the United States seeks a Quality Systems Specialist I to perform moderately complex Quality Systems activities, ensuring records remain complete, compliant, and inspection-ready. You will assist with deviations, investigations, CAPAs, change controls, and data reporting under supervision.

The role requires 1–3+ years in QA/QMS within pharma or biotech, familiarity with GMP, and strong communication with cross-functional teams.

Qualifications

• 1–3+ years of experience in Quality Assurance, Quality Systems, pharma manufacturing, biotech, or related regulated industry.
• Knowledge of GMP regulations and quality-system requirements (FDA/EU expectations).
• Experience managing or supporting deviations, investigations, CAPAs, change controls, document control, training, audits, and quality metrics.
• Experience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations preferred.
• Experience interacting with clients, regulatory agencies, and auditors.
• Strong analytical, organizational, problem-solving, and decision-making skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong written, verbal, and stakeholder-management abilities.

Responsibilities

• Support deviations, investigations, CAPAs, change controls, quality events, document revisions, and related QMS activities under supervision.
• Review quality records for completeness, accuracy, and procedural compliance.
• Coordinate with Manufacturing, Quality Control, Validation, Engineering to progress records.
• Support root-cause analysis, risk assessments, corrective actions, and effectiveness verification.
• Track records against timelines and escalate delays or risks.

Skills

GMP awareness

QA systems

Root-cause analysis

Risk assessment

Documentation control

Stakeholder management

Education

High School diploma or equivalent

Bachelor's degree in Life Sciences

Job description

PCI Pharma Services in the United States seeks a Quality Systems Specialist I to perform moderately complex Quality Systems activities, ensuring records remain complete, compliant, and inspection-ready. You will assist with deviations, investigations, CAPAs, change controls, and data reporting under supervision.

The role requires 1–3+ years in QA/QMS within pharma or biotech, familiarity with GMP, and strong communication with cross-functional teams.