Quality Systems Specialist

Quality Systems SpecialistThe Quality Systems Specialist is responsible for supporting and maintaining the company's Quality Management System (QMS) within a regulated pharmaceutical manufacturing environment. This role involves managing document control activities, authoring and revising Standard Operating Procedures (SOPs), administering employee training records, supporting audits, processing quality events such as CAPAs, deviations, and change controls, and facilitating customer quality agreements. The position requires cross-functional collaboration with Operations, Quality, Regulatory, and leadership teams to drive continuous improvement and ensure quality system compliance.Responsibilities:Manage document control activities and maintain the Quality Management System.Author and revise Standard Operating Procedures (SOPs).Administer and maintain employee training records and training matrices.Support internal and external audits.Process quality events such as CAPAs, deviations, and change controls.Facilitate customer quality agreements and respond to supplier qualification requests.Ensure compliance with cGMP, ICH, ISO, and customer requirements.Collaborate with cross-functional teams to drive continuous improvement.Essential Skills:Bachelor's degree in a scientific discipline.3-4 years of Quality Assurance experience in a cGMP, GxP, ISO-regulated manufacturing environment.Experience developing, maintaining, and improving quality systems in regulated manufacturing environments.Understanding of CAPA, deviations, change controls, complaints, audits, and training systems.Experience ensuring procedures and quality systems meet cGMP, ISO, and customer requirements.Additional Skills & Qualifications:Strong technical writing skills.Ability to investigate quality issues and perform root cause analysis.Excellent organizational and follow-up skills.Experience with audits and regulatory inspections.Strong communication skills and cross-functional collaboration.Intermediate Microsoft Office skills.Experience with electronic quality systems such as MasterControl preferred.Pharmaceutical or life sciences manufacturing experience highly preferred.Work Environment:The work environment includes standard business hours from Monday to Friday, with an onsite office and manufacturing support environment.

The role involves close collaboration with Quality, Operations, Manufacturing, Regulatory, and Management teams. It predominantly involves office-based work with extensive use of computer systems and documentation platforms in a fast-paced, regulated life sciences environment with shifting priorities and deadlines. This is a 6-month contract assignment.Job Type & Location:This is a Contract position based out of Carlsbad, CA.Pay and Benefits:The pay range for this position is $28.50 - $35.61/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.

Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)