Quality Assurance Specialist

Astrix

New York, NY

JOB DETAILS
SALARY
$30–$40 Per Hour
SKILLS
Analysis Skills, Biochemistry, Biology, Biotech and Pharmaceutical, Chain of Custody, Change Control, Chemistry, Code of Federal Regulations, Communication Skills, Continuous Improvement, Cross-Functional, Detail Oriented, Documentation, External Audit, GMP (Good Manufacturing Practices), Internal Audit, Laboratory Analysis, Laboratory Information Management System (LIMS), Manufacturing, Microsoft Office, Organizational Skills, Quality Assurance, Quality Control, Quality Management, Standard Operating Procedures (SOP), Supply Chain, Team Player, Time Management
LOCATION
New York, NY
POSTED
Today

Quality Assurance SpecialistType: Contract-to-hireShift: M-F, 1st ShiftLocation: Middlesex County, NJBase pay range$30.00/hr - $40.00/hrKey ResponsibilitiesReview and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance.Perform raw material release activities in accordance with established SOPs and GMP requirements.Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody.Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications.Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols.Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data.Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation.Participate in internal and external audits, as needed.Identify and support opportunities for continuous improvement in quality systems and documentation processes.QualificationsBachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required.2–5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry.Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles.Experience reviewing QC data, raw material documentation, and stability reports.Detail-oriented with strong organizational and documentation skills.Excellent communication and teamwork abilities.Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!#J-18808-Ljbffr

About the Company

A

Astrix