QA Associate – Document Control- Pharma (Onsite- Bothell, WA)

QA Associate Document Control- Pharma (Onsite- Bothell, WA)

We are seeking a QA Associate Document Control- Pharma (Onsite- Bothell, WA) for a global pharmaceutical client. The Quality Assurance - Records Management supports the cGMP Document Control operations for Bothell site records management. Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Bothell, WA.

Work Schedule- Sun- Thurs

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities :

Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed

Assist with Document Center Archive room activities

Knowledge of Records Management, Scanning and organization functions

Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests

Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site

Support internal and external audits and regulatory inspections. This may require data gathering, interviewing, or escorting auditors during the audit.

Assist with document retrieval / organization support during regulatory inspections.

Assist with Insurance and Reconciliation of Controlled Forms and Logbooks

Requirements :

Minimum of 3+ years of relevant document control records management experience in a cGMP / FDA regulated environment.

Experience with Part 11 adherence regarding scanning of records and electronic archiving.

Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)

Strong knowledge of cGMPs and domestic regulatory requirement

Experience in FDA / EMA regulations in biopharmaceuticals or cell therapy manufacturing are required.

Demonstrated experience with quality management systems.

Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., Content Manager Records Software)

Bachelor's degree or equivalent. Library Science a plus. High school diploma / associate's degree with equivalent combination of education and work experience may be considered.

Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the QA Associate Document Control- Pharma (Onsite- Bothell, WA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation : $40 / hr. - $43.95 / hr.

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