Job Title: Manufacturing Documentation Specialist II

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

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

Reports To: Operations Manager

Purpose:

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job.

Scope:

InvaGen Pharmaceuticals is searching for experienced candidates for the position of Manufacturing 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 to deliver timely batch record review across all shifts.
• Reviews and approval of master batch records.
• Develops appropriate disposition metrics, works with manufacturing 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 manufacturing procedures.
• Develops strategies and documents for cleaning and process validation of API 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 timelines established.
• Autonomously leads and manages projects to implement continuous improvement opportunities.
• Lead and/or support root cause investigations related to performance trends and formal deviations.
• Develops, implement and assess solutions for complex problems.
• Anticipates risk and build contingencies to help mitigate impact.
• Reviews document for accuracy and completeness.
• Defends the validation programs and strategies to customer and regulatory auditors.
• Performs weekly quality reviews of MasterControl 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 environment.
• Performs other duties as assigned.

Education and Experience

• Associate degree with 6-8 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.
• Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
• Minimum one (6) 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

• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suite.
• Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Knowledge and experience writing, revising and creating cGMP records and SOP's.
• Creation and maintenance of batch record and cGMP documentation templates.
• Closure of any compliance related CAPA's.
• Hands on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.
• Ability to work effectively both independently and as part of a team.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language
• Ability to understand and analyze complex data sets.
• Knowledge of statistical packages is a plus.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Position requires flexibility to quickly adapt to changing work environment and schedules
• Excellent organizational skills with the ability to focus on details.
• Basic computer skills (Word and Excel) - Intermediate
• Good basic math knowledge and excellent attention to details.

Work Schedule and Other Position Information:

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.
• No employment sponsorship or work visas.

GLOBAL COMPANY

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.

Cipla 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.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About 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.

EEO Statement:

Cipla 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.