Manufacturing Quality Assurance Associate

Genentech•San Diego, CA

1d•Onsite

About The Position

We are seeking an exceptional candidate to join our Quality team in San Diego, CA. The Manufacturing Quality Assurance Associate candidate will have Manufacturing Quality Assurance (MQA) related responsibilities to ensure starting materials and Clinical products meet cGMP requirements. This role reports to the Senior Quality Assurance Specialist. You will be an integral part of a friendly Quality Assurance Team that is dedicated, agile, and collaborative. In this role, you will work on-site directly with all GMP related functional teams that are committed to delivering quality products to our clinical patients. Your talents and expertise will directly contribute to the passion to develop innovative therapies with the capacity to cure. You will learn and advance in your career as this group is forward-thinking and fully supportive of career development. If you are an individual that is driven to make a difference, have a strong work ethic, and you want to be a part of an exciting bigger picture, the Quality Assurance team welcomes you! The Opportunity Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control, Procurement, and Facilities teams. Review executed production batch records and associated testing data to ensure the records meet cGMP expectations. Participate in the creation, revision, and review of basic SOPs, Forms, Work Instructions and other controlled documents within the QMS, as requested. Qualify for and perform clean room (ISO classified) gowning for all QA on-the-floor support activities for internal manufacturing processes. Perform QA line clearance activities. Perform duties related to the raw material program, and other MQA support activities as assigned Identify opportunities for improvement within the assigned roles and responsibilities and take initiative to communicate and drive positive change. Supports the use of and maintains Quality trackers as assigned. Complete other Quality Assurance based activities as assigned. Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority. Fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product.

Requirements

A minimum of a Bachelor’s degree in life sciences or a related field with a minimum of 2 years of relevant experience, GMP/GxP experience preferred (an equivalent combination of education and experience may be considered).
Knowledge of cGMP of FDA, ICH and EU regulations.
Controlled document review and /or batch release experience preferred.
Basic understanding of Deviations, CAPAs and Change Control processes.
Basic computer skills in Excel, PowerPoint, and word processing.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, and as a team member.
Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment.
Ability to support a flexible work schedule to accommodate the Manufacturing schedule.
Must be able to achieve and retain cleanroom (ISO classified) gowning qualified status
Must be physically capable to lift 20 pounds and stand for periods up to 2 hours

Responsibilities

Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control, Procurement, and Facilities teams.
Review executed production batch records and associated testing data to ensure the records meet cGMP expectations.
Participate in the creation, revision, and review of basic SOPs, Forms, Work Instructions and other controlled documents within the QMS, as requested.
Qualify for and perform clean room (ISO classified) gowning for all QA on-the-floor support activities for internal manufacturing processes.
Perform QA line clearance activities.
Perform duties related to the raw material program, and other MQA support activities as assigned
Identify opportunities for improvement within the assigned roles and responsibilities and take initiative to communicate and drive positive change.
Supports the use of and maintains Quality trackers as assigned.
Complete other Quality Assurance based activities as assigned.
Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority.
Fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product.