Analytical QA Supervisor

nalytical Quality Assurance Supervisor

Responsibilities

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.

Ensuring review, compliance and approval of laboratory raw data which includes audit trials.

Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.

ctively 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.

ssessing 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. Requirements

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.

8+ years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.

5+ years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.

Current, working knowledge of analytical quality assurance (AQA).

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 documentation Practices (GDP), USP monograph requirements, FDA & ICH guidance requirements, etc.

Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc.

Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.

Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.

Capable of conducting troubleshooting, investigations and root cause identification and analysis.

Capable of supporting and participating in compliance and regulatory audits at the local and federal levels.

Experience in Inhalation products (MDI) is a plus..

Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.