Overview
Compliance & Quality Assurance Coordinator Jobs in Cortland, NY at Catholic Charities of Cortland County
Quality Assurance Senior Staff Member for Pharmaceutical Manufacturing
Location: Fairfield, NJ
Chemspec-API is a pharmaceutical company specialized in manufacturing and R&D of Active Pharmaceutical Ingredients. We have been providing high quality products within GMP and ICH guidelines and providing research and development services to customers in all stages of drug discovery and development.
We are seeking a highly motivated individual to join us as member of our senior Quality Assurance staff. This individual will have the responsibility for all aspects of our Quality Systems.
Responsibilities
The senior QA staff member will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the FDA guidelines, as well as applicable guidelines to ICH, MHRA, EMA, USP, and BP.
Overall responsibilities for quality operations and initiatives, including
Provide Quality Assurance management
Review and approve documentation of master batch records, specifications and analytical methods.
Initiate, perform and approve investigations of complaints, deviations, CAPAs
Provide production support and Risk Assessments
Perform GMP training and SOP reviews and updates
Provide Validation / qualification documentation, review and approval
Perform QA Audits, both internal and external
Develop, maintain, and implement training programs and quality systems
Qualification Requirements
Education: BS/MS degree in chemistry or biochemistry
Experience: A minimum of five (5) years of quality assurance experience in a pharmaceutical industry preferred
Experience with FDA, client, vendor and internal audits
Extensive knowledge of US and EU current Good Manufacturing Practices
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Proficient in computer skills
Ability to Lead a Team
Knowledge of GMP’s
Excellent interpersonal and customer service skills
Excellent communications skills, both oral and written
Ability to problem solve
Ability to multi-task and balance priorities to meet timelines
Ability to work independently
Ability to work within a team, often taking a leadership role
Ability to provide and receive critical feedback
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Health insurance
Paid time off
Schedule:
Monday to Friday
Weekends as needed
Ability to Commute:
Fairfield, NJ 07004 (Required)
Ability to Relocate:
Fairfield, NJ 07004: Relocate before starting work (Required)
Work Location: In person
Title: Compliance & Quality Assurance Coordinator
Company: Catholic Charities of Cortland County
Location: Cortland, NY
