Quality Systems Specialist in Irvine, CA

Position is 100% onsite

M-F 8:30-5:00 – No OT

6 months to 1 year role

Over see skin care production

Review batch records and issuing authorizations

• Some one who has no exp with batch release will not work
• Batch release experience
• Knowledge of Cosmetic and OTC product regulations
• Cosmetic industry exp will work
• Travel to couple of CMO who are local to Irvine (not a far drive)
• Accuracy to detail
• Experience with Track wise for CAPA and change control
• Focused on releasing products
• Work on 10-20 batches in a week (some week may be heavy and some may be lighter)
• Tech transfer is not need for this role
• 5-7 yrs exp needed
• Bachelors degree needed minimum

Top 3 skills

• Knowledge of quality systems
• Batch release
• Change control

Please focus on local candidates

• The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.
• Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.
• This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
• This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural Health Products, Cosmetics, Homeopathic and Over the Counter (OTC) Drugs.

Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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 complaint 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:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• 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 ly, and across various departments.

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