QA Documentation Control Associate

Cipla • Fall River, MA

3d • Onsite

About The Position

The QA Document Control Associate in a pharmaceutical environment is responsible for managing controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its lifecycle, including creation, review, approval, distribution, and archival. The QA Document Control Associate position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders within the Quality. The essential and typically expected job duties for this position include but are not limited to the following:

Requirements

• Bachelor’s degree industrial management or related field of study from an accredited college/university is required for this position.
• Minimum of three (3) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

Nice To Haves

• Experience in MDI preferred.

Responsibilities

• Maintain the Documentation Control Room.
• Receive approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. after proper verification ensuring GDP.
• Issue the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, etc. to cross functional department based on requirements.
• Scan the document and keep them with proper naming.
• Arrange all the documents with proper naming and proper tracking within documentation control room.
• Train staff on document control procedures and Good Documentation Practices.
• Maintain the accessories/day to day item required to maintain the documentation control room.
• Support internal and external audits by providing accurate documentation packages.
• Manage controlled documents such as SOPs, batch records, validation protocols, and specifications.
• Send the document to outside agencies after proper scanning.
• Control the issuance, tracking, retrieval, and final reconciliation of all site-critical logbooks for equipment and controlled areas.
• Enforce strict adherence to Data Integrity principles (ALCOA+) and GxP documentation practices during all processing steps.
• Assist in the preparation and execution of internal and external audits by efficiently locating and retrieving requested controlled documentation.
• Involve in department QMS such as deviation, CAPA, Change Control, APQR preparation.
• Any other work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees