QA Associate II, Validation

The purpose of this position is to perform necessary and essential tasks to ensure new and existing facilities, utilities, equipment, and processes are validated and are operating under a state of control.  This role will be responsible for authoring, executing, reviewing, and approving validation protocols, reports, studies and other documentation as directed by management.  In addition, this role will work cross functionally to determine critical process parameters and tests plans to demonstrate equipment and processes are appropriate for their intend use.

General Responsibilities

  • Author detailed validation protocols, reports and analyzes complex data that demonstrate systems and equipment are appropriate for their intend use and are compliant with cGxP/CFR requirements
  • Execute validation protocols
  • Write and review SOPs
  • May coordinate validation activities with external vendors and internal stakeholders
  • Maintain equipment history files
  • Responsible for regulatory asset management software data entry including asset induction and processing validation work orders
  • Work closely with cross-functional departments as necessary to resolve issues.
  • Troubleshoot and rectify issues that are complex in nature
  • Perform detailed risk assessments of systems, software and ancillary equipment including but not limited to laboratory equipment, analytical instruments, GxP software and hardware platforms, autoclaves, and chromatography equipment
  • Determine the causes of errors as related to validation of systems and presents solutions to resolve them
  • May train lower-level personnel
  • Use mathematics to solve measurement related problems as well as to derive and interpret specifications
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Specific Responsibilities

 The successful candidate will:

  • Lead and assist in performing all tasks necessary to achieve the organization’s mission and help execute growth plans
  • Assume responsibility for assigned duties related to equipment/facility/utility and process qualifications and validations, to ensure compliance with applicable SOPs, regulations ,and safety guidelines
  • Interact and coordinate with compliance efforts across departments to provide a high degree of assurance that all qualification/validation activities are completed to requirements
  • Write protocols and reports and provide technical input to validation deviations and assessments for change requests
  • Ability to operate independently and as part of a team

Position Requirements and Experience

The desired candidate will have:

  • Experience developing and executing equipment impact assessments and validation test protocols for production facilities and equipment in a pharmaceutical cGMP regulated environment
  • Proven success in a validation role in a life science/pharmaceutical manufacturing environment.
  • Experience and expertise in communication exchanges with internal or external customers
  • A proven capability to generate shareholder value
  • Negotiation skills to maximize value in client/regulatory body discussions
  • High intelligence and problem-solving skills
  • Excellent oral and written communication skills and listening skills

Qualifications

  • A Bachelor’s degree in Engineering or Science is preferred; and five (5) or more years of progressive, relevant, experience is required
  • Time and project management skills with the ability to multi-task are essential
  • Ability to effectively build and lead teams
  • High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
  • Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferred

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

Apply for this Job

LIKE YOU, WE ARE MAKERS...
Let's discuss the right solution for your team!