Employment Type: Permanent Position

Job Category: Quality Assurance

Department: Quality Assurance

Reports To (Position): Manager, Quality Systems

Job Number: 3369522

Position Overview:

The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Manager, Quality Systems, this person will manage the creation, revision, issuance and archival of controlled documents within the company’s Quality Management System and manage document archive to ensure GxP compliance and quality oversight. This role will collaborate across the company to support the filing and archiving of GXP documentation essential to the success of the company.  

Accountabilities and Responsibilities:

Leads the establishment and maintenance of the company’s archive.

Administers the document control process in the eQMS and/or paper-based system.

Assists in developing, implementing, and/or improving archive quality processes and systems.

Scans, reconciles and archives executed documents.

Manages archive reviews and audits as necessary.

Retrieves and prints controlled documents as requested.

Performs periodic reviews of controlled documents to ensure accuracy and relevance

Supports internal and external audit/inspection requests for document retrieval

Assists in continuous improvement of document control workflows and systems

Supports the goals and objectives of the Quality organization.

Performs other duties as assigned.

Essential Details:

Work Environment

The majority of the work is performed in an office environment however, work is also performed in a lab environment; work may involve common hazards found in a lab environment. In some areas, gowning may be required. Ability to lift up to 20 lbs for archival tasks.

Minimum Requirements:

Education

Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field

Experience

• 2-4 years of relevant experience in the biotech/pharmaceutical industry
• Experience with electronic document control and/or training software is required (Veeva is preferred)
• Expertise in Microsoft Office suite of applications, particularly Access, Outlook, Word, Excel

Knowledge, Skills & Attributes

• Working knowledge of GxP requirements for documentation and document archival.
• Ability to interpret GxP requirements.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at the same time, including the ability to follow assignments through to completion and meet deadlines.
• Excellent communication (verbal and written) skills required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with a high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.