Quality Assurance Specialist III

The Quality Assurance (QA) Specialist III 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 III primarily works in the cGMP areas to manage adherence to the quality system and initiate the resolution of deviations.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

• Assist in developing and conducting training of personnel in full accordance with cGMPs and Curia’s quality system to ensure real-time compliance
• Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
• Assist in Curia documentation compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
• Author, revise and/or review and approve Quality Management System documents, including, but not limited to, SOPs, CAPAs, Deviations, Un-executed/Executed quality records, Change Controls, test methods, protocols (stability, validation, etc.), executed validation documentation, certificates of analysis and/or equipment qualification documentation
• Assist in internal and external audit programs and prepare reports as required. This may include planning audits, conducting audits and writing audit reports
• Participate in and/or perform regulatory, client, and external supplier qualification audits as well as internal audits and weekly walkthroughs
• Assist in or lead investigations
• With supervision, may respond or manage responses to clients regarding manufacturing, testing, and/or documentation issues
• Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
• Develop, support and/or maintain Quality System metrics for management review
• Support QA specialists to ensure client timelines are on schedule and attainable. This includes communicating directly with internal project teams and customer contacts
• Assist in resolving quality problems/concerns with various personnel
• Provide on the floor support and oversight to operations, including coordinating and perform day to day activities as needed
• Actively participate in quality improvement initiatives, including development and implementation
  

Education, experience, certification and licensures

Required

• Bachelor’s degree in Life Sciences or related field; alternate fields of study may be considered in combination with significant industry experience. 20 years of pharmaceutical experience will be considered in lieu of a degree.
• Minimum 6-8 years’ QA experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
• U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) hired after December 7, 2021 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.
  

Preferred

• Experience working with third-party contract manufacturing in the pharmaceutical industry
• Gowning qualification (may be required)
  

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 21CFR210 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 enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.