QA Analyst III
Responsibilities
- Reviewing and confirming the compliance related to raw materials, in process 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.
- Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
- Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same.
- Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
- Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
- 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.
- 4-8 years in analytical (preferably in analytical quality assurance for minimum of 3 years).
- 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.
- Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
- 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.
- 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.
- Effective interpersonal relationship skills and the ability to work in a team environment.
- Experience in Inhalation products (MDI/DPI) is a plus.
- Knowledge of good manufacturing practices and good documentation practices preferred.
- Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
- 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 be able to work under minimal supervision and able to work independently and in a team environment.
- Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
- 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.
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.