Manufacturing Documentation Specialist I (Pilot Plant) at InvaGen Pharmaceuticals in Fall River, MA
Location: Fall River, Massachusetts, United States
Company: InvaGen Pharmaceuticals, a Cipla Subsidiary
Job Title: Manufacturing Documentation Specialist I
Work Hours: General Shift: 8:30 AM – 4:30 PM (subject to change based on business needs)
Position Overview:
InvaGen Pharmaceuticals is seeking a skilled Manufacturing Documentation Specialist I for its Fall River, MA facility. The role focuses on developing, reviewing, and updating GMP batch production records and SOPs. The successful candidate will ensure documentation quality, compliance with regulations, and accuracy. Reporting to the Site Lead/Operations Manager, this position will collaborate with cross-functional teams to ensure smooth documentation processes.
Key Responsibilities:
- Develop and maintain documents for cleaning and process validation, ensuring alignment with SOPs and regulatory requirements.
- Provide data to support management in analyzing performance trends.
- Assist with the review and approval of master batch records.
- Support the closure of Corrective and Preventive Actions (CAPAs) related to compliance.
- Lead investigations into performance trends and deviations, performing root cause analysis.
- Track and manage the periodic review of manufacturing procedures to ensure compliance.
- Follow internal protocols, SOPs, and cGMP guidelines to maintain a compliant work environment.
- Perform other duties as assigned.
Qualifications and Experience:
- Associate degree in Life Sciences or Engineering with a minimum of 2 years of GMP manufacturing experience.
- Bachelor’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or a related field is preferred.
- At least 1 year of documentation experience, with 2 years of experience in the pharmaceutical or biotech industry. Prior experience in manufacturing generic pharmaceuticals is highly desirable.
- Solid understanding of GMP documentation and SOPs.
- Familiarity with quality systems compliance and regulatory audits.
Technical Skills:
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Experience with GMP documentation, batch records, and SOP creation.
- Strong problem-solving skills with experience in compliance and regulatory audits.
- Knowledge of pharmaceutical manufacturing processes.
- Prior experience with inhalation products (MDI) is a plus.
Professional Competencies:
- Proficiency in English, along with strong communication skills, is essential.
- Ability to analyze complex data sets and utilize statistical tools (knowledge of statistical packages is advantageous).
- Excellent organizational skills and the ability to manage multiple tasks with great attention to detail are required.
- Capable of working both independently and collaboratively in a dynamic, fast-paced setting.
Work Schedule:
- Must be willing to work in a pharmaceutical manufacturing setting, which may require first, second, or third shifts.
- Flexibility to work weekends or varied schedules based on business needs.
- Relocation assistance may be provided.
- No remote work is available.
- No sponsorship or work visas are offered for this position.
About InvaGen Pharmaceuticals (A Cipla Subsidiary):
InvaGen Pharmaceuticals, Inc., a Cipla subsidiary, is a leading developer and manufacturer of high-quality generic medications. Focused on a broad range of therapeutic areas, including cardiovascular, anti-infective, CNS, and anti-inflammatory treatments, InvaGen plays a critical role in Cipla’s mission to provide affordable and accessible healthcare solutions worldwide.
Apply Now:
If you are a detail-oriented professional with a passion for pharmaceutical manufacturing, apply for the Manufacturing Documentation Specialist I position today. Join InvaGen Pharmaceuticals and contribute to improving healthcare across the globe.
To visit official website of Cipla Careers and apply for Manufacturing Documentation Specialist I, Click Here.
Disclaimer:
This job listing is for informational purposes only. Please visit the official company website for accurate and up-to-date details.
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