Product Design Documentation

Job Description

Job Description

LHH partnered with a local company to recruit for a Product Design Documentation in Pacheco, CA.

Production Design Documentation

Compensation : $28 to $33 / hour DOE

Assignment Type : Contract - 1 year with potential to convert

Location : Pacheco, CA

About the Role :

We are seeking a detail-oriented and proactive Production Design Documentation to join our team. This role supports recombinant antibody product development and ensures compliance with design control and quality system requirements throughout the product lifecycle.

Key Responsibilities :

Product Development & Design Control

Facilitate recombinant antibody product development projects.

Draft design documents for review by the Director of New Product Development.

Assist in reviewing technical documents, including test records, data sheets, product labeling, SOPs, and other design outputs.

Edit product data sheets and revise departmental procedures.

Update documentation related to product implementations and discontinuations.

Participate in routine lab activities, including drafting purchase requisitions and ordering selected supplies.

Monitor progress of new reagent products through the Product Development Life Cycle (PDLC), coordinating with R&D, Manufacturing, QC, QA, and Marketing.

Ensure compliance with GMP requirements and assist in organizing test results, drafting documentation, proofreading, and preparing grading forms.

Support oversight of antibody raw material inventory in R&D.

Required Competencies :

Strong understanding of IVD development, including Design Controls, Quality System Regulations, ISO 13485, MDSAP, and IVDR requirements.

Knowledge of immunohistochemistry and in situ hybridization protocols and assays.

Ability to work independently with minimal supervision.

Exceptional attention to detail and organizational skills.

Excellent verbal and written communication skills for presenting complex information.

Proficiency in Microsoft Office and project management tools.

Demonstrated ability to maintain good housekeeping and organizational habits.

Pay Details : $28.00 to $33.00 per hour

Search managed by : Joyce Reyes

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer / Veterans / Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.