Documentation Specialist - 2nd Shift

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:Documentation Specialist - 2nd Shift - MFG/PKG
FLSA Classification:Professional, Exempt
Work Location: Fall River, MA
Work Hours: 2nd Shift: 3:00PM - 11:30PM (may vary based on business needs)
Reports To:Manufacturing/Packaging Manager
Salary Range: $66,300- $86,000

Job Overview
Invagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist. 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. This position reports to the Site Lead/Operation Manager and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.

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... For full info follow application link.

Cipla USA and its US Affiliates 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.