AQA QA Associate IIMerck & Co. Inc • Central Islip, New York, United States
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AQA QA Associate II
Merck & Co. Inc
- Central Islip, New York, United States
- Central Islip, New York, United States
À propos
Job Title QA Associate II AQA
FLSA Classification Professional, Exempt
Work Location Central Islip, NY
Work Hours General: 8:30AM - 5:00PM (may vary based on business needs)
Reports To Quality Assurance Manager
Salary Range $86K- $95K
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:
Scope The Analytical Quality Assurance (AQA) associate II III position is a team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Hauppauge, NY.
Job Duties
Reviewing and confirming compliance related to raw materials, inprocess and finished product analytical documents.
Monitoring and ensuring current Good Laboratory Practices (cGLP) are 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.
Preparing and reviewing laboratory investigation (OOS/OOT/Deviation) reports and ensuring compliance.
Verifying 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 SOPs.
Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams.
Maintaining all incoming documents with proper tracking, recording, storage and archival of the documents.
Reviewing and identifying gaps within the system during routine monitoring and informing the supervisor of necessary improvements.
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.
Education and Experience
Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field from an accredited institution. Master’s degree preferred.
Minimum of 4-8 years in analytical experience (preferably in analytical quality assurance for a minimum of 3 years).
Proficient computer skills and software applications such as Microsoft Office and quality applications.
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 including 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.
Experience in inhalation products (DPI) is a plus.
Professional and Behavioral Competencies
Strong communication skills; able to communicate clearly and concisely at all levels.
Strong documentation and technical writing skills.
Self‑starter, demonstrates initiative, works independently and in team.
Can work any assigned shift ranging from first or second shift; Monday–Friday (with possible weekend/holiday work).
Knowledge of good manufacturing practices and good documentation practices preferred.
Excellent organizational skills with focus on detail.
Work Schedule and Other Position Information
General shift but must be willing to work any assigned first or second shift; shift schedules may be Monday–Friday, Tuesday–Saturday, or combinations based on needs.
Must be willing to work some weekends as required.
Relocation negotiable.
No remote work; must work in a cGMP laboratory or manufacturing environment with PPE.
Work shift may be Day, Evening, or Night; weekend or holiday work may be requested.
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Compétences linguistiques
- English
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