Quality Assurance Specialist II

Curia•Albany, NY

About The Position

The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist II primarily works in the cGMP areas to manage adherence to the quality system and assist in and/or initiate the resolution of deviations. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

BA/BS Degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
OR
MA/MS Degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
Excellent written and verbal presentation and communication skills
Strong facilitation skills
Strong problem-solving skills, with the ability to resolve conflict
Ability to effectively present information to management and/or peers
Comfortable working independently and proactively in combination with individuals in other departments across the organization
Focused self-starter with attention to detail and ability to multi-task
Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211
Working knowledge of Microsoft Office or other software as needed

Responsibilities

Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
Review quality control testing for compliance with internal SOPs and specifications
Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
Perform and/or participate in internal audits, external audits, investigations, and/or inspections
With supervision, may respond or manage responses to clients regarding manufacturing, testing and/or documentation issues
May develop and/or maintain Quality System metrics for management review
Provide on the floor support to operations, including coordinating and performing day to day activities as needed
May assist in developing and conducting training of personnel to execute production in full accordance with cGMP’s and Curia’s quality system to ensure real-time compliance
May perform QA visual inspection activities when required
Participate in regulatory and client audits
Other duties as assigned.