Technical Writer

Seeking 1 Technical Writer

Hybrid Role- Must be onsite 3 days in Parsippany, NJ

Description:

Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMO batch records, disposition, deviations, CAPAs, change controls, CAPAS, and inspection management.

Responsible for reviewing CMO's deviations, CAPAs, and change controls related to biologic intermediate and final drug product manufacturing (i.e., mAb, drug substance, drug product), process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.

Independently review, initiate, complete, and thoroughly document critical, major, and minor deviations, CAPAs, and change controls at CMO's within Gilead's document control system; and Gilead internal quality events related to GxP operations.

Participate in developing of or provides review and feedback for Standard Operating Procedures to ensure quality objectives are met.

Participate in cross-functional meetings with stakeholders and leadership to ensure alignment and compliance to EQO expectations.

Supports management and monitoring of quality events for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases.

Supports the maintenance and improvement of quality systems processes, as needed.

Participate post-inspection risk assessments of CMO regulatory inspections, identify, and implement improvements as needed.

Works directly with operating entities and internal clients to ensure follow-up of deviations, CAPAs, and change controls.

Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

Additional Skills & Qualifications:

Experience in a GxP-regulated biopharmaceutical environment.

Demonstrates proficiency in Good Manufacturing Practices (GMPs).

Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.

Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.

Demonstrates Project Management and critical thinking skills to manage multiple quality events of varying complexity and scope of tasks in a fast-paced environment to meet timelines.

Experience and familiarity with aseptic and/or biologics drug substance manufacturing practices and guidelines.

Demonstrate knowledge and application of risk management principles, including identification, controls, mitigations, and actions.

Demonstrates excellent verbal and written communication skills to all levels of the organization. Technical writing skills required.

Demonstrate ability to problem solve and lead process improvements.

Demonstrate ability to lead cross-functional meetings and make decisions as QA representative.

Demonstrates strong interpersonal skills with ability to influence, negotiate, manage conflict, and negotiate.

Demonstrates proficiency in Microsoft Office applications.

Education and Experience

6+ years of relevant experience in a GMP environment for biologics manufacturing and a BS or BA, with Deviations/Change Controls/CAPAs experience a must.

Individual has majority of this experience doing technical writing w/in the pharma industry.

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.