Cipla USA · 4 weeks ago
Quality Assurance Analyst I
Fall River, MA
Full-time
Onsite
Entry Level
$62K/yr - $75K/yr
1+ years expCipla USA is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. They are seeking a Quality Assurance Analyst I to contribute to the Analytical Quality Assurance team, ensuring compliance with laboratory practices and reviewing analytical documents.
Pharmaceuticals
Responsibilities
Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents
Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure
Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs)
Review of laboratory audit trials during data review against standard operating procedures (SOPs)
Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams
Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents
Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas
Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance
Performing other departmental and cross-functional projects and assignments given by the manager/supervisor
Qualification
Required
Possess a minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution
A minimum of 1-3 years in analytical (preferably in analytical quality assurance)
Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs
Knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Documentation Practices (GDP), etc
Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews
Effective interpersonal relationship skills and the ability to work in a team environment
Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting
Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally
Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices
Must be able to work under minimal supervision and able to work independently and in a team environment
Proficiently speak English as a first or second language and ability to read, write and communicate effectively the same
Must be a self-starter and demonstrate initiative to seek additional training or direction as needed
Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday
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
Must be willing to work some weekends based on business needs as required by management
Preferred
Master's degree in the above and/or related fields of study as noted above preferred
Experience in Inhalation products (MDI) is a plus
Knowledge of good manufacturing practices and good documentation practices preferred
Benefits
Benefits and participation in a bonus program based on performance and company results.
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
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