- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 ... Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment...controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11,… more
- Twist BioScience (South San Francisco, CA)
- …departments, including Quality Assurance, Regulatory Affairs, Supplier Quality , Supply Chain, Quality Control , Production, Process Development, ... in a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices, IVD, EU… more
- Insmed Incorporated (NJ)
- … archives.Partner with cross-functional teams ( Regulatory Affairs, CMC, Clinical, Quality ) to facilitate document authoring, review, approval, and publishing ... content and metadata within Veeva Submissions Vault, ensuring compliance with document management standards, version control , and audit readiness.Coordinate the… more
- Cipla (Central Islip, NY)
- … standards and regulatory requirements. Understanding of regulatory compliance, quality management systems and document control processes, and the ... knowledge of analytical techniques (HPLC, GC, UV-Vis etc.) and familiarity with quality control procedures. Responsible for performing routine analytical testing… more
- Merck & Co. (Rahway, NJ)
- …CMC regulatory content Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform ... Preferred Experience and Skills Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document … more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- Quality Assurance & Regulatory Manager Valencia...revision process of old procedures as necessary to maintain Quality Control and Quality Assurance ... The Job Eckert & Ziegler Isotope Products seeks a Quality Assurance & Regulatory Manager to join...Experience in design control , manufacturing, process development, quality assurance, quality control . Ability… more
- Insmed Incorporated (NJ)
- …You Are:You have a Bachelor's degree along with 2+ years of experience ona document control team using a quality management system, with preference ... and develop key metrics on documentation status and compliance using the Veeva Quality Management System to ensure alignment with regulatory and internal … more
- Cipla (Fall River, MA)
- …programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have ... the company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Department Head - Manufacturing… more
- Cipla (Fall River, MA)
- …the proper documentation of all quality systems and records. Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work ... monitoring etc. Preparation and review of the Annual Product Quality Review. Fulfil the requirement of regulatory ...Product Quality Review. Fulfil the requirement of regulatory submission while closely working with regulatory … more
- Cipla (Fall River, MA)
- …programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have ... company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Manufacturing/Packaging and partners… more
- Cipla (Hauppauge, NY)
- …product integrity. Affixing approved labels on the approved materials, once release from quality control after testing. Review and verify artwork proofs for ... products and packaging materials are stored within required conditions to maintain quality . Document and track any discrepancies found during inspections,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …related fieldSolid understanding of regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory ... to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to… more
- Insmed Incorporated (NJ)
- …operational performance data to identify trends and opportunities for continuous improvement.Oversee quality control and audit readiness, serving as a subject ... will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance/ regulatory mandates and quality requirements. Complying with company policies ... in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory … more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance/ regulatory mandates and quality requirements. Complying with company policies ... in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory … more
- Cipla (Fall River, MA)
- …in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory ... procedures. Daily monitoring of production performance. Perform manufacturing processes and document activities in batch records and logbooks. Machine operation with… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance/ regulatory mandates and quality requirements. Complying with company policies ... in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory … more
- Cipla (Fall River, MA)
- …in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory ... compliance to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Ensure proper...timely removal from unit by coordinating with unit QA. Control and handle the damaged container as per SOP.… more
- Cipla (Fall River, MA)
- …on time, ensuring accuracy and completeness. Adhering to all cGMPs, compliance/ regulatory mandates and quality requirements. Complying with company policies ... in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory … more
- AUROBINDO (Durham, NC)
- …experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several ... training forms in a timely manner and forward to document control for archival.Perform other duties as...player able to effectively communicate with QA Supervisor, IPQA, Quality Control , Production, Warehouse, Engineering and Supply… more
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