Job Description
Position overview The Quality Assurance (QA) Specialist I is responsible for maintaining Quality databases and
providing an on-the-floor QA presence and oversight to manufacturing operations. This
position's role will include identifying compliance risks in the operation prior to and during
execution, avoiding deviation whenever possible as well as managing immediate corrective
action such that a) adherence to cGMPs and internal procedures/policies are maintained, and
b) appropriate immediate corrective action is implemented and effectively documented in
order to provide traceability and substantiation of any claims to be made in the investigation.
This position primarily works in the cGMP production areas to manage adherence to the
quality system and to initiate and assist in the initiation and 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 1. Maintain Quality databases including Archival and scanning of cGMP documents and
records, Departures, media fill programs, and training files
2. Represent Curia Quality Assurance when managing issues that require immediate
corrective action. Ensure such action taken is appropriate and correctly documented
3. Solicit feedback from various departments for operational improvement
4. Author, review, and/or approve Quality Management System documents, including,
but not limited to, change controls, SOPs, deviations, CAPAs, etc.
5. Assist in performing investigations
6. Perform and/or assist with internal audits, weekly walkthroughs, and/or external audits
7. Perform QA visual inspection activities associated with clinical and commercial drug
product
8. With supervision, may respond or manage responses to clients regarding
manufacturing and/or documentation issues
9. Develop and/or maintain Quality System metrics for management review
10. Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and
CAPAs
Please see the attached job description. Within that the main focus will be reviewing executed GMP documentation including:
- Batch Records
- QC release testing
- In-process data
- Cleaning records
- Logbooks
- Shipping records
- Product labels
Required Associates' degree in Life Science or related field
Minimum 0-3 years' experience in a cGMP and FDA-regulated industry
Preferred Bachelor's degree in Life Science or related
Knowledge, skills and abilities 1. Excellent verbal and written communication skills
2. Focused self-starter with attention to detail
3. Team-oriented, but able to work independently and proactively
4. Ability to multi-task
5. Strong problem solving and organizational skills
6. Strong critical thinking skills, including familiarity with root-cause analysis
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Job Tags
Local area, Immediate start,