QA Analyst I

at  Cipla

FLSA Classification: Professional, Exempt
Work Location: Fall River, MA
Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)
Reports To: Quality Assurance Manager

EDUCATION AND EXPERIENCE

• Possess a bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master’s degree in the above and/or related fields of study as noted above preferred.
• A minimum of eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
• Experience using statistical software packages is a plus.
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
• Current, working knowledge of quality assurance (QA).
• Strong 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 Distribution Practices (GDP), etc.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• 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.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• 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.
• Must be able to exercise appropriate professional judgment on matters of significance.

This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following:
Scope:
The Quality Assurance (QA) Senior Specialist position is an individual contributor role and reports to the Quality Assurance Manager for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

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

• Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Verifying the standard operating procedures (SOPs) and test procedures.
• Verifying process validation and characterization-related documents.
• Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).
• 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 for necessary improvements in the identified areas.
• Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
• Evaluating and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
• Conducting random internal audits in analytical lab and ensuring the compliance.
• Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Performing other departmental and cross-functional projects and assignments given by the manager.