{"schemaVersion":"jobsearcher.job.v1","id":"7a99f8b43518f07e23ca2d7b","url":"https://jobsearcher.com/jobs/7a99f8b43518f07e23ca2d7b","canonicalUrl":"https://jobsearcher.com/jobs/7a99f8b43518f07e23ca2d7b","title":"PKG. Documentation Specialist II","description":"Job Title: Pkg. Documentation Specialist II\nFLSA Classification: Professional, Exempt\nWork Location: Fall River, MA\nWork Hours: General Shift: 8:30AM – 5:00PM (may vary based on business needs)\nReports To: Department Head – Manufacturing\nSalary Range: $72,800 - $93,600\n\nJob Overview\n\nInvagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist.\n\nThe 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 Department Head - Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.\n\nThe job duties for this position include but are not limited to the following:\n\nWorks with Manufacturing/Packaging to deliver timely batch record review across all shifts.\nReviews and approval of master batch records.\nDevelops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency\nCreates training materials for subject matter input.\nTrack and manage periodic review of approved procedures.\nDevelop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.\nProvides data to support management evaluation of performance trends.\nOwns quality records (change control, CAPA’s, deviations) and delivers to established timelines.\nAutonomously leads and manages projects to implement continuous improvement opportunities.\nLead and/or support root cause investigations related to performance trends and formal deviations.\nDevelop, implement and assess solutions for complex problems.\nAnticipates risk and builds contingencies to help mitigate impact.\nReviews document for accuracy and completeness.\nDefends the validation programs and strategies to customers and regulatory auditors.\nPerforms weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.\nFollows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.\nPerforms other duties as assigned.\n\nEducation and Experience\n\nAssociate degree with 4-6 years knowledge and experience of GMP documentation required.\nBachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university.\nMaster’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.\nMinimum two (2) years documentation experience and four (4) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.\n\nTechnical Knowledge and Computer Systems Skills\n\nExcellent communication skills, drive, and sense of urgency\nExcellent computer skills, specifically Microsoft Office Suite.\nSolid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.\nFollow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.\nMust have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.\nKnowledge of pharmaceutical manufacturing and related documents.\nKnowledge and experience writing, revising and creating cGMP records and SOP’s.\nKnowledge of GDP.\nCreation and maintenance of batch record and cGMP documentation templates.\nClosure of any compliance related CAPA’s.\nHands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.\nAbility to work effectively both independently and as part of a team.\nCapable of handling and participating in compliance and regulatory audits at the local and federal levels.\nExperience using SAP business system and applications is a plus.\nExperience in Inhalation products (MDI) is a plus.\nKnowledge and handling of deviation, CAPA, change control, FMECA, OOS, OOT, training and OOAC.\nKnowledge and handling of SAP system, master control and TrackWwise system.\nKnowledge of preparation of BMR and eBMR.\nKnowledge of preparation of SOP and eLog books.\nDuring audit part of team.\nPlanning of batches as per production plan.\nKnowledge of audits and compliance.\n\nProfessional and Behavioral Competencies\nProficiently speak English as a first or second language\nAbility to understand and analyze complex data sets.\nKnowledge of statistical packages is a plus.\nKnowledge of good manufacturing practices and good documentation practices preferred.\nAbility to read, write and communicate effectively.\nSelf-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.\nPosition requires flexibility to quickly adapt to changing work environment and schedules\nExcellent organizational skills with the ability to focus on details.\nBasic computer skills (Word and Excel) – Intermediate\nGood basic math knowledge and excellent attention to details.\nWork Schedule and Other Position Information:\nMust be willing to work in a pharmaceutical manufacturing setting.\nMust be willing to work some weekends based on business needs as required by management.\nRelocation negotiable.\nNo remote work available.\n\nGLOBAL COMPANY\n\nCipla 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.\n\nCipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.\n\nCIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)\n\nAbout InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.\n\nCipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.","company":"Cipla","rawCompany":"cipla","city":"Fall River","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:28:52.546Z","occupations":[{"code":"15-1299.03","title":"Document Management Specialists","slug":"document-management-specialists"},{"code":"29-1051.00","title":"Pharmacists","slug":"pharmacists"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325411","title":"Medicinal and Botanical Manufacturing","slug":"medicinal-and-botanical-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"PKG. Documentation Specialist II","description":"Job Title: Pkg. Documentation Specialist II\nFLSA Classification: Professional, Exempt\nWork Location: Fall River, MA\nWork Hours: General Shift: 8:30AM – 5:00PM (may vary based on business needs)\nReports To: Department Head – Manufacturing\nSalary Range: $72,800 - $93,600\n\nJob Overview\n\nInvagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist.\n\nThe 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 Department Head - Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.\n\nThe job duties for this position include but are not limited to the following:\n\nWorks with Manufacturing/Packaging to deliver timely batch record review across all shifts.\nReviews and approval of master batch records.\nDevelops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency\nCreates training materials for subject matter input.\nTrack and manage periodic review of approved procedures.\nDevelop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.\nProvides data to support management evaluation of performance trends.\nOwns quality records (change control, CAPA’s, deviations) and delivers to established timelines.\nAutonomously leads and manages projects to implement continuous improvement opportunities.\nLead and/or support root cause investigations related to performance trends and formal deviations.\nDevelop, implement and assess solutions for complex problems.\nAnticipates risk and builds contingencies to help mitigate impact.\nReviews document for accuracy and completeness.\nDefends the validation programs and strategies to customers and regulatory auditors.\nPerforms weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.\nFollows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.\nPerforms other duties as assigned.\n\nEducation and Experience\n\nAssociate degree with 4-6 years knowledge and experience of GMP documentation required.\nBachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university.\nMaster’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.\nMinimum two (2) years documentation experience and four (4) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.\n\nTechnical Knowledge and Computer Systems Skills\n\nExcellent communication skills, drive, and sense of urgency\nExcellent computer skills, specifically Microsoft Office Suite.\nSolid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.\nFollow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.\nMust have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.\nKnowledge of pharmaceutical manufacturing and related documents.\nKnowledge and experience writing, revising and creating cGMP records and SOP’s.\nKnowledge of GDP.\nCreation and maintenance of batch record and cGMP documentation templates.\nClosure of any compliance related CAPA’s.\nHands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.\nAbility to work effectively both independently and as part of a team.\nCapable of handling and participating in compliance and regulatory audits at the local and federal levels.\nExperience using SAP business system and applications is a plus.\nExperience in Inhalation products (MDI) is a plus.\nKnowledge and handling of deviation, CAPA, change control, FMECA, OOS, OOT, training and OOAC.\nKnowledge and handling of SAP system, master control and TrackWwise system.\nKnowledge of preparation of BMR and eBMR.\nKnowledge of preparation of SOP and eLog books.\nDuring audit part of team.\nPlanning of batches as per production plan.\nKnowledge of audits and compliance.\n\nProfessional and Behavioral Competencies\nProficiently speak English as a first or second language\nAbility to understand and analyze complex data sets.\nKnowledge of statistical packages is a plus.\nKnowledge of good manufacturing practices and good documentation practices preferred.\nAbility to read, write and communicate effectively.\nSelf-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.\nPosition requires flexibility to quickly adapt to changing work environment and schedules\nExcellent organizational skills with the ability to focus on details.\nBasic computer skills (Word and Excel) – Intermediate\nGood basic math knowledge and excellent attention to details.\nWork Schedule and Other Position Information:\nMust be willing to work in a pharmaceutical manufacturing setting.\nMust be willing to work some weekends based on business needs as required by management.\nRelocation negotiable.\nNo remote work available.\n\nGLOBAL COMPANY\n\nCipla 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.\n\nCipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.\n\nCIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)\n\nAbout InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.\n\nCipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.","datePosted":"2026-04-14T10:28:52.546Z","dateModified":"2026-04-14T10:28:52.546Z","hiringOrganization":{"@type":"Organization","name":"Cipla","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Fall River","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7a99f8b43518f07e23ca2d7b"},"url":"https://jobsearcher.com/jobs/7a99f8b43518f07e23ca2d7b"}}