GENERAL POSITION OVERVIEW
The Quality Assurance (QA) Senior Analyst position is an individual contributor role and reports to the Senior Manager of Analytical QA for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary (also known as Cipla New York). 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, in�process 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.
PROFESSINAL COMPETENCIES AND TECHNICAL SKILLS
- 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.
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.
- 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.
OTHER JOB INFORMATION
- Relocation negotiable.
- No employment sponsorship.
- No remote work available.
- Must be willing to work some weekends based on a relevant business need, if required.