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 Ciplas 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: $66300-$70000

Job Overview

The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as this role the Documentation Specialist adheres to the companys document and SOPs 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 CAPAs 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.
• Bachelors degree in science biochemistry pharmaceutical engineering Pharmaceutical Sciences or related discipline from an accredited college/university preferred.
• Masters 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 timemanagement skills with the ability to prioritize multiple tasks in alignment with departmental and sitewide objectives.
• Ability to work independently as a selfstarter and collaboratively within a dynamic crossfunctional teambased 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 fastpaced 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 handson 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 (BMR/eBMR) eLogbooks and documentation templates.
• Knowledge and handling of deviations CAPAs change controls FMECA OOS OOT training records and OOAC.
• Experience supporting compliance activities including participation in local and federal regulatory audits.
• Ability to facilitate problem solving and root cause investigations and to develop implement and assess solutions to complex issues.
• Responsible for closure of compliancerelated CAPAs.

Systems Data and Planning

• Experience with electronic quality and document management systems such as SAP MasterControl and TrackWise preferred.
• Ability to understand analyze and interpret complex data sets; experience with statistical analysis tools is a plus.
• Knowledge of batch planning and execution in accordance with production plans

Benefits

In addition to a fulfilling career and competitive salary the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching health insurance medical/dental/vision health savings account (HSA) flexible spending account (FSA) paid time off (PTO) vacation/sick/flex time paid holidays short-term disability (STD) long-term disability (LTD) parental leave paid and unpaid family leave employee discounts and other benefits.

About Cipla

Cipla is a leading global pharmaceutical company dedicated to high-quality branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades we have strengthened our leadership in Indias pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India South Africa the U.S. and other economies of the emerging world. Driven by the purpose of Caring for Life Ciplas focus has always been on making affordable world-class medicines with a reputation for uncompromising quality standards across the world.

In the last 85 years Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development manufacture marketing and distribution of generic prescription medicines with focus on a range of therapeutic areas including cardiovascular anti-infective CNS anti-inflammatory anti-diabetic and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge New October 2020 InvaGen established its project site in Fall River Massachusetts to support the launch of Ciplas respiratory business in the United States.

Equal Opportunity Employer

Race Color Religion Sex Sexual Orientation Gender Identity National Origin Age Genetic Information Disability Protected Veteran Status or any other legally protected group status.

At Cipla we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one please contact the recruiter.

About the Salary/ Pay Range

The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience skills education and budget. Salary range may vary based on geographic addition to base salary this position may be eligible for benefits and participation in a bonus program based on performance and company results.