Analyst, Quality Control

**The Role**:
Reporting to the Quality Control Associate Director, the individual in this role will perform cGMP QC testing for QC Chemistry, release, and stability. He/she will also be responsible for supporting Global GMP stability programs, stability sample set down, pull, and sample shipment/receipt activities. Additionally, the individual in this role will be involved in routinely maintaining of stability databases, performing data trending and statistical analyses, creation, revision, review and approval of SOP’s, stability protocols and stability reports in accordance with current GMP, FDA, EU and ICH guidelines and regulations; this individual may support special projects as assigned.

**Here’s What You’ll Do**:
Performs routine analytical chemistry & stability testing including, but not limited to HPLC, UPLC, GC, UV, Particle Analysis by Dynamic Light Scattering, KF, etc.

Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed.

Complete and maintain cGMP documentation for work performed.

Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.

Establish and maintain a safe laboratory working environment.

LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS.

Assists with and executes on ordering of laboratory consumables and supplies. Managing/stocking of QC lab supplies.

Performs stability responsibilities in compliance and in support of any stability program and associated SOP’s.

Creates, reviews and revises stability protocols and reports.

Assists with and performs stability set down and stability pull activities to include, but not limited to labeling, verifying sample quantities, and updating in LIMS and/or appropriate logs/inventory sheets; Supports routine stability sample inventory management, assessment, and sample disposal activities.

Assists with creating stability schedules for GMP stability drug substances and drug products and ensures stability sample pulls occur and are distributed to the test labs as scheduled and within appropriate timelines.

Performs the required functions for stability studies in LIMS, including data entry review and approval.

Assists with and supports reporting of stability testing results both externally and cross-functionally.

Performs trending of stability data and statistical analyses and maintains/ keeps current stability tables and charts for all stability studies.

Supports and executes stability sample shipments to external labs; Requests and retrieves stability testing data/reports from external vendors and shared folders and updates in-house stability binders and databases accordingly.

Supports review and authoring of applicable stability sections for regulatory submissions.

May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.

Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.

**Here’s What You’ll Bring to the Table**:
BA/BSc in Chemistry (preferred) or other relevant scientific discipline.

**Working experience**: at least 5-7 years in quality control laboratory of a pharmaceutical company.

**Le rôle**:
Relevant du directeur associé du contrôle de la qualité, la personne occupant ce poste effectuera des tests de contrôle de la qualité conformes aux BPF pour la chimie du contrôle de la qualité, la libération et la stabilité. Il/elle sera également responsable de soutenir les programmes de stabilité conformes aux BPF mondiaux, l'établissement des échantillons de stabilité, le prélèvement et l'expédition/réception des échantillons. De plus, la personne occupant ce poste participera régulièrement à la maintenance des bases de données de stabilité, à l'analyse des tendances des données et aux analyses statistiques, à la création, à la révision, à l'examen et à l'approbation des PON, des protocoles de stabilité et des rapports de stabilité conformément aux directives et réglementations actuelles des BPF, de la FDA, de l'UE et de l'ICH ; cette personne peut également soutenir des projets spéciaux qui lui sont assignés.

**Voici ce que vous ferez**:
Effectuer des tests de chimie analytique et de stabilité de routine, notamment HPLC, UPLC, GC, UV, analyse de particules par diffusion dynamique de la lumière, KF, etc.

Effectuer des dosages HPLC (AEX) et des dosages basés sur un lecteur de plaques NaOH pour soutenir les tests statistiques du processus de fabrication, au besoin.

Compléter et tenir à jour la documentation conforme aux BPF pour les travaux effectués.

Effectuer des activités générales de soutien au laboratoire, notamment la préparation des réactifs, la gestion des échantillons, la maintenance de l'équipement, l'entret