Massachusetts Jobs

Job Title: Quality Assurance Specialist I – Document Control

FLSA Status: Non-Exempt 1st shift (0830-1700), M-F

Department: Quality

Reporting To: Site Manager, Quality Systems and Compliance

About the Position

The Document Specialist in Quality Assurance will provide support to the cGMP compliance function at Curia. This role will be responsible for the processing, formatting, obtaining of approvals, mastering, distributing and archiving of Standard Operating Procedures (SOPs), Forms, Batch Records, Protocols, logbooks, project notebooks and Material Specifications. Critical thinking, attention to detail, and excellent written and verbal communication skills are essential to the position.

Supervisory Responsibilities

This position does not have supervisory responsibilities.

Position Responsibilities

Other duties may be assigned

• Authors and revises Standard Operating Procedures

• Act as subject matter expert for electronic document management system

• Participate in document identification and revision development.

• Manage new and revised documents through review, approval, and distribution (electronically and physically)

• Provide support to Manufacturing and QA Operations

• Assign/issue document change notification controlled-number, track and process through closure

• Responsible for logbook and lab notebook issuing, tracking and reconciliation

• Responsible for master batch records; creation, revision, and control

• Assemble, verify, and issue executable batch records

• Generates, issues, and verifies QC in-process testing labels

• Reviews executed documents prior to sending to clients and archival

• Facilitates the orderly storage and retrieval of documents, ensuring movement of documents and records in and out of the archive is controlled and documented

• Provides audit support for client, internal, and regulatory audits – archived document retrieval, back room support, and/or scribing.

• Assists in quality investigations as needed

• Interacts with various personnel from all departments in activities listed above

• Proficient in the area of document control and familiarized with current regulations and cGMP’s.

Position Requirements

Education:

Associates’ degree in related field required; Bachelors’ degree preferred

Relevant Work Experience:

Minimum 1-3 years’ direct experience in GMP environment

Knowledge, Skills & Abilities

• Familiarity with the regulatory requirements of 21 CFR parts 210, 211, and 11

• Knowledge and understanding of specific systems such as TrackWise Digital and Noverant

• Excellent written/oral communication skills; verbally expresses ideas and facts in a clear, logical, and concise manner using acceptable grammatical style

• Effectively communicate issues, provide alternative solutions, and resolve in a timely manner

• Focused self-starter with attention to detail

• Team-oriented but able to work independently and proactively

• Ability to multi-task in a high throughput environment

• Strong problem solving and organizational skills

• Ability to read, understand, interpret and implement technical writing and instructions

• Familiar with normal cGMP terminology

Proficient in the use of MS Word, Excel, PowerPoint, Outlook and SharePoint, as this individual will perform work within these systems on a routine basis

Physical Demands

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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