GMP Packaging Documentation Specialist - Relocation Negotiable

Cipla USA; Fall River (MA); On-site; USD 66,000 - 86,000; Full time

Job summary

Cipla USA seeks a Packaging Documentation Specialist - MDI in Fall River, MA. The role focuses on creating and revising GMP batch production records and SOPs, ensuring accuracy and compliance under cGMP guidelines.

Reports to Packaging Manager and collaborates with cross-functional teams to maintain documentation integrity. The ideal candidate has strong experience with GMP documentation, SAP and TrackWise, and holds relevant degrees with preference for pharma-related advanced credentials.

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.

Responsibilities

• Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.
• Reviews and approval of master batch records.
• Develops disposition metrics and reports on targets to improve processes.
• Creates training materials for subject matter input.
• Tracks periodic review of approved procedures and SOPs.

Skills

GMP documentation

SAP

TrackWise

Master Control

Education

Associate degree in GMP documentation

Bachelor’s degree in science / related field

Master’s degree in Pharmaceutical Engineering/Sciences

Tools

SAP

Master Control

TrackWise

Job description

Cipla USA seeks a Packaging Documentation Specialist - MDI in Fall River, MA. The role focuses on creating and revising GMP batch production records and SOPs, ensuring accuracy and compliance under cGMP guidelines.

Reports to Packaging Manager and collaborates with cross-functional teams to maintain documentation integrity. The ideal candidate has strong experience with GMP documentation, SAP and TrackWise, and holds relevant degrees with preference for pharma-related advanced credentials.