RCI-ABBV-28650 Quality Systems Specialist (Pharma/Medical Device/Biotech)

Rangam; Irvine (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Quality Systems Specialist to ensure compliance with quality assurance and regulatory standards. This role involves overseeing product quality, assisting project teams with new launches, and ensuring adherence to cGMPs and corporate compliance. You'll collaborate with cross-functional teams, create quality documentation, and contribute to training programs. If you have a passion for quality systems and thrive in a dynamic environment, this opportunity is perfect for you!

Qualifications

• Knowledge of quality assurance and control in pharma/medical devices.
• Ability to work in teams and ensure regulatory compliance.

Responsibilities

• Ensure products meet quality system requirements and regulatory standards.
• Assist in planning new product launches and tech transfers.

Skills

Knowledge of Cosmetic and OTC product regulations

Teamwork

Quality assurance and quality control

Regulatory compliance

Job description

RCI-ABBV-28650 Quality Systems Specialist (Pharma/Medical Device/Biotech)

Position is 100% onsite

M-F 8:30-5:00 – No OT

Please focus on local candidates

Base pay range: $43.00/hr - $45.00/hr

Responsibilities

• Responsible for various aspects of quality assurance and quality control related to products produced.
• Ensures that product is consistently manufactured in conformance with Client Quality System requirements and all applicable regulatory requirements.
• Supplier oversight, assuring responsible Third Parties are compliant with cGMPs, regulatory and corporate compliance requirements and contractual agreements as applicable.
• Assist project teams in planning new product launches and tech transfer.
• Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation. Responsible for developing a process to maintain citation history. Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the Client Record Retention Schedule.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Contribute and prepare training and education programs for various aspects of quality assurance.

Qualifications

• Knowledge of Cosmetic and OTC product regulations and guidance, including new product introductions and tech transfer highly preferred.
• Ability to work in a team, both in person and remotely, and across various departments.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance, Engineering, and Analyst

Industries

Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research