Technical Writer, Manufacturing

Location
Oceanside, CA
Posted
Apr 27, 2022
Ref
2990080
Required Education
High School or equivalent
Position Type
Full time

Technical Writer, Manufacturing

Overview

We are seeking a Technical Writer to support our clinical manufacturing facility in Oceanside, CA that includes GMP areas for bioprocessing. Under minimal supervision, this position is accountable for technical writing deliverables in support of manufacturing operations while closely collaborating with Quality Assurance (QA), Engineering, Quality Control (QC), and Technical Operations (TO).

Responsibilities (include but are not limited to):
  • Perform all tasks associated with Quality Systems Record Management
  • Deviation ownership - In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
  • CAPA ownership - Devises and implements Corrective and Preventative Actions to address root cause and ensure effectiveness collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents as support is needed
  • Change Management ownership – Initiate necessary changes resulting from corrective actions.
  • General operational excellence changes to GMP documents (batch records, SOPs, forms, use logs, etc.)
  • Support Manufacturing and collaborate with Technical Operations, Quality Assurance, Quality Control, Supply Chain and Facilities on assigned tasks.
  • Execute and collaborate with manufacturing on Human Error Reduction and Right First Time Initiatives.
  • Maintain Quality Record/Tech Writing Team metrics, identify and support improvement efforts with Tech Writer Lead.
  • Maintain on-time completion of all required training.
  • Maintain gowning certification.
  • Other tasks and duties as assigned by Management.


Basic Qualifications:
  • Master's degree with 2+ years or a Bachelor's degree with 4+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry or an AA degree with 5+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry or a High School degree with 6+ years of experience in science/engineering, manufacturing and quality in biotech/pharma industry


Preferred Qualifications:
  • Cell culture and/or Purification bioprocess experience.
  • Broad technical knowledge of cGMP compliance and experience with leading investigations, authoring deviation reports, change management, and corrective actions.
  • Experience with investigation and root cause analysis tools (Pareto, 5-Why's, Fishbone diagram, Failure Mode and Effects Analysis etc.).
  • Experience with creating and delivering presentations.
  • Proficiency in using Microsoft Word, Excel, and Project.
  • Utilizes technical writing strategies to ensure content is clear and concise.
  • Possesses good verbal communication skills.
  • Ability to think critically, with demonstrated troubleshooting and problem-solving skills. Takes initiative in solving issues.
  • Strong understanding of the Manufacturing Process.
  • Ability to support shift work and potential overtime


About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our

growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.


For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.








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