Quality Assurance Associate

Belcan; Sanford (NC); On-site; USD 93,100 - 146,300; Full time

Job summary

A leading quality assurance consulting firm is seeking a Quality Assurance Associate in Sanford, NC. The candidate will oversee QA processes to ensure compliance with local and global standards within the biologics manufacturing sector. Responsibilities include reviewing validation documents and authoring quality documents. Ideal candidates should have a relevant degree and 3-5 years of experience in QA functions. This is a mid-senior level contract role offering competitive compensation ranging from $93,100 to $146,300 annually.

Qualifications

• 3-5+ years of experience in a QA function in a biologics manufacturing facility.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities.
• Strong understanding of FDA and ICH guidelines.

Responsibilities

• Provide hands-on QA support and oversight to ensure compliance with quality standards.
• Review and approve commissioning/qualification/validation documents.
• Author and review controlled documents for the Quality organization.

Skills

Understanding of FDA regulations

Analytical skills

Communication skills

Problem-solving skills

Teamwork

Education

B.S. in Biological/Physical/Chemical sciences or equivalent

Job description

Direct message the job poster from Belcan

Keyword's: #Sanfordjobs; #AssuranceAssociatejobs.

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

Seniority level

Mid-Senior level

Employment type

Contract

Job function

• Quality Assurance
• IT Services and IT Consulting

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Location: Sanford, NC; Salary: $93,100.00-$146,300.00 (2 weeks ago)