Manufacturing Documentation Specialist

4 weeks ago

Fall River, Massachusetts, United States Cipla Full time
Job Title: Manufacturing Documentation Specialist

Job Summary:

Cipla is seeking a highly skilled Manufacturing Documentation Specialist to join our team in Fall River, MA. As a key member of our operations team, you will be responsible for creating and revising GMP batch production records and SOPs, ensuring accuracy, quality, and integrity.

Key Responsibilities:

* Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.
* Provide data to support management evaluation of performance trends.
* Assist with review and approval of master batch records.
* Assist with closures of any compliance-related CAPAs.
* Lead and/or support root cause investigations related to performance trends and formal deviations.
* Track and manage periodic review of approved manufacturing procedures.
* Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.

Requirements:

* An associate degree in life sciences or engineering with 2 years of GMP manufacturing experience.
* Bachelor's degree in pharmaceutical engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university with knowledge and experience of GMP documentation preferred.
* Minimum one (1) year documentation experience and two (2) 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.
* Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring 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.
* Experience with quality system compliance.
* 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.

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.
* 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.

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.

About InvaGen Pharmaceuticals:

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.

Equal Opportunity Employer:

Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Pre-employment Process:

Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing.

Disclaimer on Pay Ranges:

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.

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