Production Specialist

Job Title: Production Specialist

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: First Shift: 7:00AM – 3:30 PM (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. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations.

Scope:

Invagen Pharmaceuticals is searching for experienced candidates for the position of Production Specialist. The person chosen will be assigned to one of two shifts.

The Production Specialist ensures compliance with cGMP’s, InvaGen Pharmaceutical’s policies, standard operating procedures, and FDA requirements. The incumbent will serve as a key resource for conducting product complaints, supports packaging, packaging components within approved procedures and regulatory requirements. This position reports to the Site Lead/Operations Manager at InvaGen Pharmaceuticals, Inc, Fall River, MA.

The job duties for this position include but are not limited to the following:

• Performs raw material and component review to ensure correct quantities, labeling and visual appearance.
• Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging.
• Follow Master Batch Records for the packaging of MDIs dosage forms when required.
• Identify defects and report quality issues.
• Set up, operate, and clean in compliance with batch records and SOPs, packaging equipment.
• Clean and sanitize packaging equipment per SOPs.
• Complete accurate and timely documentation. Follow good documentation practices in accordance with cGMP.
• Perform in-process testing and inspections as required by Master Batch Record (weighing, visual inspection etc.).
• Effectively performs activities and applies knowledge in accordance with approved SOPs, company policies, regulatory requirements, schedules and provides technical expertise and direction to colleagues.
• Actively participate in Production team and Site communication meetings.
• Support GMP investigations and events.
• Contribute to Standard Operating Procedure (SOP) writing in technical area.
• Understands and operates all necessary equipment and instrumentation to perform activities.
• Maintains documentation in accordance with internal procedures and regulatory requirements (i.e., GMP, SOPs etc.).
• Interfaces with appropriate Warehousing, Planning, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.
• Performs activities for manufacturing (i.e., batch record review, packaging line clearances and manufacturing room clearances, deviations, etc.).
• Notifies immediate supervision of any issues related to job function and recommends solutions in a timely manner.
• Comprehend and adhere to all pertinent EHS regulations, policies and procedures and the required use of all approved and issued Personal Protective Equipment.
• Responsible for compliance with documentation and accountability procedures and policies, maintaining high alert to diversions.
• Demonstrates a level of consciousness to safety and health related activities as evident by the daily application of requirements specific to job function; recognize safety and health related issues and report to management.
• Independently searches, gathers, and presents information to support compliance with regulations and internal systems.
• Ensure and compliance with safety, quality, productivity, and performance expectations and execution of manufacturing and packaging operations.
• Manage performance and train assigned employees using Company systems, procedures, policies, practices, and other tools to meet established performance standards, productivity targets, and overall business requirements.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
• Perform other duties as assigned.

Education and Experience

• Bachelor’s degree in pharmaceutical engineering, Pharmaceutical Sciences or related field of study from an accredited college/university required.
• Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• 3+ years’ experience in a pharmaceutical setting preferred.
• General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Packaging with serialization preferred.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language.
• Ability to read, write and communicate effectively.
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• A strong understanding of work discipline, Chain of Command and Teamwork
• Able to apply knowledge and experience to complex problems and offer recommendations.
• High standards in Safety, Environmental, and Leadership
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• 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.

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.