Quality Assurance Specialist II

Location: Rensselaer

Quality Assurance Specialist II in Rensselaer, NY

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

+ Generous benefit options (eligible first day of employment)

+ Paid training, vacation and holidays (vacation accrual begins on first day of employment)

+ Career advancement opportunities

+ Education reimbursement

+ 401K program with matching contributions

+ Learning platform

+ And more!

Position overview

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.

Essential job duties

+ 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.

Education, experience, certification and licensures Required

· 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

Knowledge, skills and abilities

+ 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 21

CFR
210 and 211

+ Working knowledge of Microsoft Office or other software as needed

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to…