QA Document Control Associate

Job Title: QA Document Control AssociateFLSA Classification: Full-Time, ProfessionalWork Location: Fall River, MAWork Hours: General Shift: 08:30 AM 5:00 PM (May vary based on business needs)Reports To: QA QMS LeadSalary Range: $64,272 $77,662

PURPOSE

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.

JOB DESCRIPTION

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:

• 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.
  

EDUCATION AND EXPERIENCE QUALIFICATIONS

• Bachelors 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.
• Experience in MDI preferred.
  

KNOWLEDGE, SKILLS, AND ABILITIES

• 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.
  

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in Indias pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Ciplas focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.

Cipla

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