MDI - Documentation Specialist Trainee - Production

NOTICE:
The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates

Job Title:

MDI
- Documentation Specialist Trainee
- Production

Employment Type:

Full Time / Exempt

Location:

Fall River, MA

Work Hours:

General

Shift: 8:30AM - 5:00PM (may vary based on business needs)

Salary Range: $66,300-$70,000

Job Overview

The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role, the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity.

The job duties for this position include but are not limited to the following:

* Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.

* Reviews and approval of master batch records.

* Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency

* Creates training materials for subject matter input.

* Track and manage periodic review of approved procedures.

* Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.

* Provides data to support management evaluation of performance trends

* Owns quality records (change control, CAPA's, deviations) and delivers to established timelines.

* Autonomously leads and manages projects to implement continuous improvement opportunities.

* Lead and/or support root cause investigations related to performance trends and formal deviations.

* Develop, implement and assess solutions for complex problems.

* Anticipates risk and builds contingencies to help mitigate impact.

* Reviews document for accuracy and completeness.

* Defends the validation programs and strategies to customers and regulatory auditors.

* Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.

* Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.

* Performs other duties as assigned.

Education and Experience

* 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 preferred.

* 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.

Technical Knowledge and Computer Systems Skills

* Proficient in Microsoft Office Suite, with intermediate skills in Word and Excel.

* Strong organizational and time‑management skills with the ability to prioritize multiple tasks in alignment with departmental and site‑wide objectives.

* Ability to work independently as a self‑starter and collaboratively within a dynamic, cross‑functional, team‑based environment.

* Demonstrated attention to detail, strong analytical skills, and solid basic math proficiency.

* Ability to read, write, and communicate effectively in English.

* Flexible and adaptable, with the ability to thrive in a fast‑paced manufacturing environment and adjust quickly to changing priorities and schedules.

GMP, Compliance, and Quality Systems Knowledge

* Working knowledge of pharmaceutical manufacturing operations and associated documentation.

* Knowledge and hands‑on experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and Standard Operating Procedures (SOPs).

* Experience writing, revising, and creating cGMP records, SOPs, batch records…