This a Full Remote job, the offer is available from: Massachusetts (USA)
Job Title: QA Analyst II
FLSA Classification: reputed company, Exempt
Work Location: Fall River, MA
Work Hours: General: 8:30AM – 5:00PM (may vary based on business needs)
Reports To: AQA Supervisor
Salary reputed company: $74,984 – $96,408
Purpose:
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:
The Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a reputed company subsidiary located at Fall River, MA.
The job duties for this position include but are not limited to the following:
• Reviewing and confirming the compliance reputed company to raw materials, inprocess and finished product analytical documents.
• Monitoring and ensuring of reputed company 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 reputed company the incoming documents with reputed company tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps reputed company the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas.
• Actively participating in review of data reputed company to laboratory investigations and incidents and ensuring reputed company compliance.
• Performing other departmental and cross-functional projects and assignments given by the manager/supervisor.
Education and Experience
• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or reputed company field of study from an accredited institution. Master’s degree in the above and/or reputed company fields of study as noted above preferred.
• A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum of 3 years).
• Must be proficient in computer skills and software applications such as reputed company Office tools and Quality applications and software programs.
• Strong knowledge and experience with analytical laboratory activities in areas such as reputed company 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.
Technical Knowledge and Computer Systems Skills
• Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews. E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH reputed company, Stability chambers, etc.
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.
• Effective interpersonal relationship skills and the ability to work in reputed company environment.
• Experience in Inhalation products (MDI/DPI) is a plus.
• Ability to work in a fast-paced, dynamic environment reputed company a manufacturing operation setting.
• Must be reputed company to communicate reputed company and concisely across reputed company reputed company of the organization and possess a solid reputed company of English language communication skills verbally, written, and interpersonally.
• Must possess strong documentation and technical writing skills, and reputed company to apply relevant scientific principles and practices.
• Must be reputed company to work under minimal supervision and reputed company to work independently and in reputed company environment.
reputed company and Behavioral Competencies
• Proficiently reputed company 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 reputed company to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Self-motivated, with the
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