Quality Assurance Associate

Job Title: Quality Assurance Associate
Location: Sanford, NC
Zip Code: 27330
Duration: 6 Months
Pay Rate: $43.92/hr
Keyword's: #Sanfordjobs; #QualityAssurancejobs.
Start Date: Immediate

Job Description:
Responsibilities and Accountabilities:
* Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
* Provide QA review and approval for commissioning/qualification/validation documents.
* Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
* Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.

Qualifications:
* B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility
* Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
* Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
* Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects
* Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
* Excellent problem-solving skills and experience with root cause investigations and CAPA determination
* Off hours coverage and flexibility may be required

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.