GMP Packaging Documentation Specialist

RXinsider LTD.; Fall River, Northern (MA, KY); Hybrid; USD 66,000 - 86,000; Full time

Job summary

InvaGen Pharmaceuticals, Inc. in Fall River, MA is seeking a Packaging Documentation Specialist for the MDI line.

The role creates and revises GMP batch production records and SOPs, ensuring accuracy and compliance while partnering with cross-functional teams under the Packaging Manager. The position requires GMP documentation experience and degrees in science-related fields; relocation is negotiable and no remote work is available.

Qualifications

• Associate degree with 1-3 years knowledge and experience of GMP documentation required.
• Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university.
• Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
• Minimum one (1) year documentation experience and three (3) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Responsibilities

• Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.
• Reviews and approval of master batch records.
• Develops appropriate disposition metrics and reports on metrics regularly.
• Creates training materials for subject matter input.
• Tracks and manages periodic review of approved procedures.
• Develops strategies for cleaning and process validation per SOPs and regulatory guidance.
• Provides data to support management evaluation of performance trends.
• Owns quality records and delivers to established timelines.
• Leads and manages projects to implement continuous improvement opportunities.
• Leads root cause investigations related to performance trends and deviations.
• Develops solutions for complex problems and mitigates risks.
• Reviews documents for accuracy and completeness.
• Defends validation programs to customers and regulatory auditors.
• Performs weekly quality reviews of Master Control database and ensures new documents.
• Follows cGMP and SOPs; monitors the environment and regulatory regulations.
• Performs other duties as assigned.

Skills

GMP documentation

SOP compliance

Data analysis

Communication

Education

Associate degree in GMP documentation

Bachelor’s degree in science/related

Master’s degree preferred

1 year documentation experience + 3 years pharma/biotech

Tools

SAP

TrackWise

Job description

InvaGen Pharmaceuticals, Inc. in Fall River, MA is seeking a Packaging Documentation Specialist for the MDI line.

The role creates and revises GMP batch production records and SOPs, ensuring accuracy and compliance while partnering with cross-functional teams under the Packaging Manager. The position requires GMP documentation experience and degrees in science-related fields; relocation is negotiable and no remote work is available.