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 (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 compliance‑related 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 India’s 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’, Cipla’s 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 York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s 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 location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.