Manager, Document Control

Quva • ,

11h • Onsite

About The Position

The Manager, Document Control is responsible for the maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory requirements. The Manager, Document Control ensures quality assurance / data integrity requirements, processes and procedures are followed. This person will identify risks and evaluate deficiencies while working with stakeholders to appropriately mitigate them. This position is responsible for Quva’s Quality Documentation program including electronic batch records and managing the Documentation system (SOPs, Forms, Specification, etc.), master batch records creation and storage, off-site document storage, and records retention. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.

Requirements

• Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
• 5+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role
• Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP)
• Knowledgeable in Quality Management Systems
• Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints
• Ability to audit GxP processes and Quality Management Systems
• Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit report
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Sense of urgency, accountability, and resourcefulness (e.g., work in changing environment)
• Self-starter, independent learner
• Communication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
• Efficiency with MS Office suite

Responsibilities

• Accountable & responsible for creation and revisions of SOPs, WIs, Policies, and other Quva documents in compliance with cGMP regulations
• Accountable & Responsible for Document Change Requests (DCR)
• Accountable & Responsible for DCR Creator/Revisor Instructor Lead Training (ILT)
• Supports training activities for batch record/logbook issuance & archiving
• Accountable for batch record and logbook issuance and archiving
• Assures compliance with cGMP regulations, Quva Pharma standards, and applicable regulatory requirements
• Drives improvement of processes of the quality system
• Performs assigned tasks and work to achieve company goals and department objectives
• Tracks and/or manages Corrective and Preventative Action (CAPA) actions as they apply to Data Integrity Compliance
• Assists in customer and/or regulatory audits
• Verification of templates and SKU data
• Check eBR and assign template in Infor for new SKUs
• Verify Quva field data for entries created for eBR and maintain as necessary
• Assist MC with template creation as necessary
• Infor integration-provide information as necessary
• Update SOP and MC role matrix for eBR responsibilities

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Manager