Manager, Document Control

This is a fully remote position, open to applicants in United States.

📋 Description

• Responsible for the development and updates of SOPs, WIs, Policies, and other Quva documentation in adherence to cGMP regulations.

• Responsible for managing Document Change Requests (DCR).

• Responsible for leading training for DCR Creator/Revisor Instructor Lead Training (ILT).

• Aids in training initiatives concerning batch record/logbook distribution and archiving.

• Oversees the issuance and archiving of batch records and logbooks.

• Ensures compliance with cGMP regulations, Quva Pharma standards, and relevant regulatory requirements.

• Promotes process enhancements within the quality system.

• Executes assigned responsibilities to meet company objectives and departmental goals.

• Monitors and/or manages Corrective and Preventative Action (CAPA) activities related to Data Integrity Compliance.

• Assists during customer and regulatory audits.

• Verifies templates and SKU data.

• Reviews eBR and assigns templates in Infor for new SKUs.

• Confirms Quva field data for entries created for eBR and maintains it as required.

• Provides assistance to MC with template creation as needed.

• Supplies necessary information for Infor integration.

• Updates SOP and MC role matrix for eBR responsibilities.

⛳️ Requirements

• A Bachelor’s Degree in Science or a related field is required (preferred areas include Chemistry, Microbiology, or Biology).

• A minimum of 5 years of relevant experience in the pharmaceutical field, ideally in biotechnology within a Quality role.

• Strong understanding of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).

• Familiarity with Quality Management Systems.

• Proven ability to write and conduct a thorough QA technical review of root cause investigations, OOS, and complaints.

• Capability to audit GxP processes and Quality Management Systems.

• Experience in reviewing CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit reports.

• Must be 18 years of age or older.

• Ability to successfully pass a drug and background check.

• Must be authorized to work in the United States on a full-time basis; Quva is unable to sponsor applicants for work visas.

🏝️ Benefits

• Consistent full-time work schedule.

• Comprehensive health and wellness benefits, including medical, dental, and vision coverage.

• 401k retirement plan with company matching.

• 22 paid days off plus 8 paid holidays each year.

• Opportunities for occasional weekend and overtime work with prior notice.

• Join a national, industry-leading high-growth company with opportunities for future career advancement.