Quality Assurance Specialist (Document Control)

The QA Specialist position is an integral part of Genentech's Pharma Technical - Hillsboro Innovative Therapies (HIT) Compliance and Document Control team dedicated to ensuring the highest standards of document management and control for innovative cell therapies. As an integral member of the team, you will collaborate with various inter-site and intra-site departments to maintain compliance with Roche/Genentech policies and Health Authority regulations.

In this role, you will play a crucial part in ensuring compliance with regulatory requirements and maintaining a state of inspection readiness. You will be responsible for a broad range of topics including, but not limited to, Quality, Safety, Health and Environmental Services (SHE), training, metrics, documenting systems and processes, the Quality Management System, audit support, and system administration.

The Opportunity:

• You will coordinate document lifecycle management activities including editing, printing, routing, retrieving, and archiving through use of the Electronic Document Management System (EDMS) and other business support tools

• Issue GMP-controlled documents to relevant departments as needed

• Maintain oversight of the Periodic Review Process for released documents and ensure compliance with Document and Records Management policies

• Coordinate and execute the Print for Reconciliation (PfR) process to ensure the proper printing, retrieval and archival of GMP documents

• Represent Quality on cross-functional and multi-site teams, ensuring efficient execution of document control activities

• Provide training to internal customers on policies and procedures for the Document Control

• You will foster an engaging work environment, promote a continuous improvement mindset, and ensure compliance with safety, health, and environmental requirements.

• You will utilize your expertise and technical knowledge to implement and sustain Document Control systems in a simplified manner, ensuring efficiency and effectiveness

• Support health authority inspections and internal audits, including acting as a Subject Matter Expert (SME)/presenter for Document Control

Who You Are:

• You hold a Bachelor's degree or equivalent with at least 3 years of experience in a related scientific discipline and have experience working in the pharmaceutical or biopharmaceutical industry, with knowledge of cGMP, SOPs, and compliance requirements in a manufacturing environment

• You possess technical proficiency in Quality systems and strong knowledge of cGMPs or equivalent regulations to ensure compliance

• You possess excellent communication skills with the ability to influence stakeholders at all levels

• Ability to prioritize multiple tasks and projects simultaneously while maintaining a high level of accuracy and attention to detail

• Proven capability for systems thinking, with strong social skills and an emphasis on understanding and addressing the needs of various stakeholders

Preferred Qualifications/Requirements:

• Previous experience with Cell and/or Gene therapies

• Experience working in electronic document management systems such as Veeva

• Strong technical writing ability

Physical Requirements:

• Work in an office environment

• Lift up to 25 lbs may be required

• Ability to sit, stand, and move within work space for extended periods

• May be required to sit at a computer terminal for extended periods

Relocation benefits are not approved for this posting.

This is an on-site role; remote options are not available.

The expected salary range for this position based on the primary location of Oregon is $67,500 - $125,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

#LI-CA1

#ptcareers

#cellandgenetherapycareers#

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.