Top 1055 Regulatory specialist Jobs in Los Angeles Ca

Quality Assurance Specialist - Document Control
Xseer Pharmaceuticals —Los Angeles, CA
- $80,000 - $87,000 a year
- Full-time
- Background check
- Mid-level
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Regulatory Affairs Specialist II
City of Hope —Duarte, CA
- $40.82 - $63.27 an hour
- Full-time
- Mid-level
- Master's degree
- Bachelor's degree
Program Analyst (Public Records Specialist)
The State Bar of California —Los Angeles, CA
- $92,960 - $123,943 a year
- Full-time
- Hybrid work
- Word processing
- Writing skills
- Mid-level
Quick Apply
Clinical Research Regulatory Specialist
Keck Medical Center of USC —Los Angeles, CA
- $75,968.95 - $101,364.43 a year
- Full-time
- Background check
- 3 years
- Bachelor's degree
Regulatory Affairs Specialist II
Prolacta Bioscience —Duarte, CA
- $43.75 - $49.00 an hour
- Full-time
- Hybrid work
- Mid-level
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
13d
Customer Experience Category Specialist
Quince —Los Angeles, CA
- $26 an hour
- Remote
- Background check
- Writing skills
- Continuous improvement
- Paid training
- Health insurance
Food Technologist Regulatory Specialist
GOLDEN WEST TRADING, INC —Vernon, CA
- $68,000 - $82,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Regulatory Affairs Specialist
Sakura Finetek USA, Inc. —Torrance, CA
- Extended hours
- Word processing
- Research
- Analysis skills
R&D - Regulatory Compliance Specialist II
Pulmuone Foods USA, Inc. —Fullerton, CA
- $80,000 - $90,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- English
- Disability insurance
- Health insurance
Quick Apply
Clinical Research Regulatory Specialist
USC —Los Angeles, CA
- $75,968.95 - $101,364.43 a year
- 3 years
- Bachelor's degree
- Continuous improvement
Accreditation and Regulatory Specialist (Glendale)
Adventist Health —Glendale, CA
- $89,603 - $134,404 a year
- Full-time
- Mid-level
- Experience equivalent to degree accepted
- Associate's degree
Specialist - Quality & Compliance
Nippon Express USA —El Segundo, CA
- $60,000 - $84,000 a year
- Full-time
- Microsoft Outlook
- Mid-level
- Office
- Commuter assistance
- Health savings account
Regional Regulatory Specialist
Flourish Research —Northridge, CA
- $25 - $26 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
Pharmacovigilance Specialist
InfoQuest Consulting Group Inc. —Los Angeles, CA
- Email
- Nursing
- Mid-level
- Office
Clinical Documentation Integrity Specialist
UCLA Health —Los Angeles, CA
- $100,161.36 - $218,718.00 a year
- RN License
- Computer literacy
- Mid-level
Legal Data Entry Specialist
InfoQuest Consulting Group Inc. —Los Angeles, CA
- Email
- Microsoft Outlook
- Computer literacy
- Quality control
Regulatory Permitting Specialist
Rainmaker Technology Corporation —El Segundo, CA
- $100,000 - $120,000 a year
- Bachelor's degree
- Continuous improvement
- Travel
Quick Apply
Quality Specialist
Hims & Hers —Los Alamitos, CA
- $70,000 - $85,000 a year
- Full-time
- Remote
- Microsoft Outlook
- Word processing
- Mid-level
- Employee stock purchase plan
- Health insurance
Sr. Regulatory Affairs Specialist - Ad/Promo
Prolacta Bioscience —Duarte, CA
- $112,000 - $125,000 a year
- Full-time
- Hybrid work
- 6 years
- Residential
- Bachelor's degree
- Health insurance
- Paid time off
Quick Apply
Supplier Senior QA Specialist
Liquid I.V. —El Segundo, CA
- $90,200 - $135,400 a year
- Monday to Friday
- Bachelor of Science
- Office
- Analysis skills
- Paid holidays
- Disability insurance

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Quality Assurance Specialist - Document Control

Xseer Pharmaceuticals
Los Angeles, CA

Quick Apply

Job Details

Full-time
$80,000 - $87,000 a year

Benefits

Health insurance
Dental insurance
Paid time off

Qualifications

USP 797
Document control experience within pharmaceutical industry
Quality management
Manufacturing facility experience
Analysis skills
Quality assurance
Bachelor's degree
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Pharmacy
Chemistry
Computer skills
Quality audits
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

The QA Specialist plays a critical role in supporting quality assurance and document control activities within a 503B outsourcing facility. This position ensures that quality records, controlled documents, and QA systems are maintained in compliance with FDA 503B requirements, cGMP standards, and internal procedures. The QA Specialist will support document lifecycle management, investigations, validations, change controls, training documentation, record retention, and continuous improvement activities.

Job Activities and ResponsibilitiesQuality Systems & Documentation

Support the management and execution of CAPAs, deviations, investigations, and change controls.
Assist in drafting, revising, formatting, routing, approving, issuing, and retiring SOPs, batch records, forms, specifications, protocols, reports, and other controlled documents.
Maintain document-control workflows within the electronic quality management system.
Verify that controlled documents are reviewed and approved by appropriate personnel before issuance.
Assign or coordinate document numbers, revision numbers, effective dates, periodic review dates, and document classifications.
Maintain current and obsolete versions of controlled documents and ensure only approved versions are available for use.
Coordinate document issuance, distribution, reconciliation, retrieval, archival, and destruction activities.
Maintain document-control logs, master document lists, revision histories, and archival records.
Review documents for completeness, consistency, formatting, proper references, approval status, and compliance with good documentation practices.
Support periodic review of SOPs, forms, specifications, batch records, and other controlled documents.
Assist with the review, issuance, reconciliation, and archival of executed batch records, logbooks, controlled forms, labels, and quality records.
Ensure superseded documents are promptly removed from points of use and appropriately archived.
Support correction and remediation of documentation deficiencies identified during QA review.
Assist with training-document issuance, curriculum updates, training assignments, and maintenance of training records.
Support record-retention activities in accordance with internal procedures and applicable regulatory requirements.
Participate in document review and approval workflows within the document-control system.

Quality Operations Support

Collaborate with cross-functional teams, including Production, QC, Engineering, and Supply Chain, to ensure required quality documentation is available, current, and completed on schedule.
Track document-review timelines, approval status, periodic reviews, overdue records, and other document-control metrics.
Support QA review of production records, validation documents, laboratory records, equipment documentation, and supporting quality records.
Assist with validation documentation, including protocols, reports, and summary documents for equipment, process, cleaning, and computer systems.
Coordinate the collection, review, and archival of supporting documentation associated with validation and qualification activities.
Support completion and closure of quality-system records by ensuring required documentation, attachments, approvals, and references are present.

Compliance & Inspection Readiness

Ensure controlled documents and QA records are complete, traceable, audit-ready, and aligned with FDA and cGMP expectations.
Support internal audits and external regulatory inspections, including FDA, DEA, and State Board of Pharmacy inspections.
Retrieve and organize requested documents and records during audits and inspections.
Assist with preparation of document indexes, inspection-request logs, evidence packages, and supporting records.
Participate in mock audits and inspection-preparation activities.
Support periodic review of document-control practices to ensure continued compliance with internal procedures and regulatory expectations.
Identify missing, overdue, incomplete, or obsolete documents and coordinate correction with the responsible department.

Continuous Improvement

Identify and propose improvements to document-control processes, document templates, review workflows, record-retention practices, and quality systems.
Support implementation of QA process enhancements aligned with operational goals and compliance standards.
Assist with standardization of document formats, naming conventions, templates, and approval workflows.
Support development and monitoring of document-control and quality-system metrics.
Participate in remediation activities related to documentation errors, overdue reviews, training gaps, and record-management deficiencies.

Qualifications

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field.
2–4 years of experience in Quality Assurance or document control in a pharmaceutical or 503B manufacturing environment.
Working knowledge of cGMP, FDA 503B guidance, USP <797>, <800>, and <85> requirements.
Strong written and verbal communication skills, with excellent attention to detail.
Proficient with document-control systems and tracking tools, such as Qualio, MasterControl, MS Project, and Excel.

Preferred

Experience in sterile compounding, aseptic manufacturing, or regulated drug production.
Knowledge of validation lifecycle and quality risk-management principles.
Familiarity with electronic quality management systems and controlled-documentation practices.
Experience with controlled-document issuance, revision, archival, periodic review, and record retention.

Minimum Qualifications

3–5 years working in a related industry.

Other Responsibilities

Collaborate with different teams to coordinate documentation timelines necessary to meet the production schedule.
Support cGMP production-facility activities.

Physical Requirements

Good hand-eye coordination.
Ability to repeatedly sit and stand for periods of time.
Ability to lift up to 30 lbs.

Reports To

QA Manager or as assigned.

Appearance

Must wear clean scrubs when in the facility.

Job Type: Full-time

Pay: $80,000.00 - $87,000.00 per year

Benefits:

Dental insurance
Health insurance
Paid time off

Application Question(s):

This position is expected to be on-site, between the hours of 8am to 430pm, Monday through Friday. Are you able to meet these expectations?
No Visa Assistance is available at this time. Are you authorized to work without a sponsored visa?

Experience:

Quality assurance: 2 years (Preferred)
Quality management: 2 years (Preferred)

Ability to Commute:

Los Angeles, CA 90025 (Required)

Work Location: In person

Quick Apply

Refine Your Search

regulatory specialist jobs in los angeles ca

Quality Assurance Specialist - Document Control

Regulatory Affairs Specialist II

Program Analyst (Public Records Specialist)

Clinical Research Regulatory Specialist

Regulatory Affairs Specialist II

Customer Experience Category Specialist

Food Technologist Regulatory Specialist

Regulatory Affairs Specialist

R&D - Regulatory Compliance Specialist II

Clinical Research Regulatory Specialist

Accreditation and Regulatory Specialist (Glendale)

Specialist - Quality & Compliance

Regional Regulatory Specialist

Pharmacovigilance Specialist

Clinical Documentation Integrity Specialist

Legal Data Entry Specialist

Regulatory Permitting Specialist

Quality Specialist

Sr. Regulatory Affairs Specialist - Ad/Promo

Supplier Senior QA Specialist

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