Sr. Quality Assurance Quality Control - Biopharma

Sanford, United States | Posted on 03/04/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Sanford
• State/Province North Carolina
• Country United States

AtBiostrategenix, we believe that simplicity is the key to quality compliance. Our philosophy is grounded inlean principles, where every process is designed to reduce complexity, eliminate waste and enhance value.

We approach quality with clarity and purpose by designing systems that are intuitive, scalable, and aligned with global regulatory expectations. Our goal is to empower our clients' teams with tools and processes that workforthem, not against them. In this way, the solutions we implement endure the test of time.

Biostrategenix LLC is hiring NOW for a contract, on-site role for aSenior Quality Assurance professional specializing in Quality Controlfor a large bio-pharmaceutical client. The contract, on-site role isbased in Sanford, North Carolina. This role provides quality assurancefor Quality Control (QC) departments that supports end-to-endmanufacturing activities for both clinical and commercial products.

Thus, in this role, you will oversee quality control and quality assurance processes, ensuring compliance with Good Manufacturing Practice (GMP) standards, review and approve procedures and documents,QC equipment qualifications, material, process control documents,deviations, CAPAs and change controls.

What You Will Be Doing

As part of the Quality Assurance team, you will

• Maintain regulatory compliance in accordance with cGMPs
• Contribute to completion of projects, manage your time appropriately to meet agreed targets, and develop plan for work activities on your own assignments/projects within a team
• Review and approve campaign related documentation as required such as MBRs, sample plans, analytical/QC documentation, LIMSbuilds, potential to SAP builds, stability protocols, and technical documents, and all associated to QC support
• Review and approve deviations, complaints, laboratory investigations, or any other associate documents that require aRoot Cause Analysis for a proper CAPA and effectiveness check
• Review and approve changes controls and provide impact assessments as required
• Drive compliance, efficiency and process improvement projects
• Represent QA in Tier meetings (triage, analytical, technical,and process robustness team meetings)
• Participate in cross-functional teams as required wherequality representation is required; interface with R&D, QC,Operations, Engineering, Supply Chain, Technical Operations,Regulatory Affairs, as applicable
• Escalate issues on time to management, as appropriate, andseek feedback in a timely manner
• Perform and assist with additional duties as needed

What We Are Looking For

Education

BS/BA in science/related field and 5+ years of experience inbio-pharmaceutical/pharmaceutical industry

MS/MA in science/related field and 3+ years of experience inbio-pharmaceutical/pharmaceutical industry

Strongly Preferred

Experience with data integrity requirements (21 CFR Part 11, Annex 11, etc.)

Experience with pharmacopeia requirements (e.g. USP, JP, EP, etc.)

Experience in QCcGMP laboratory environment (analytical or microbiology)

knowledge of cGxPand regulatory requirements for clinical and commercial DP/DS

Strong expertise in Quality Control, including proficiency in analytical technique sand ensuring product quality

Proven experience in Quality Assurance

Proficiency in Quality Management and oversight of quality-related processes

Excellent analytical, organizational, and communication skills

Excellent attention to detail, leadership skills, and practical problem-solving abilities

Ability to be flexible with changing priorities

Preferred

Experience inanalytical method transfer within a cGMP environment

Knowledge ofaseptic DP process

Experience with leansix sigma/continuous improvement methodologies

Relevantcertifications or training in quality management, GMP, or auditingare advantageous

Contract position. This position does not qualify for relocation benefits.

Biostrategenix LLC is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.