Sr. Quality Assurance for Quality Control - Biopharma - Contract

Biostrategenix LLC•Sanford, NC

46d•Onsite

About The Position

Biostrategenix LLC is hiring NOW for a contract, on-site role for a Senior Quality Assurance professional specializing in Quality Control for a large bio-pharmaceutical client. The contract, on-site role is based in Sanford, North Carolina. This role provides quality assurance for Quality Control (QC) departments that supports end-to-end manufacturing 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, LIMS builds, 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 a Root 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 where quality representation is required; interface with R&D, QC, Operations, Engineering, Supply Chain, Technical Operations, Regulatory Affairs, as applicable Support equipment lifecycle qualification activities Escalate issues on time to management, as appropriate, and seek feedback in a timely manner Perform and assist with additional duties as needed

Requirements

BS/BA in science/related field and 5+ years of experience in bio-pharmaceutical/pharmaceutical industry
MS/MA in science/related field and 3+ years of experience in bio-pharmaceutical/pharmaceutical industry

Nice To Haves

Experience with data integrity requirements (21 CFR Part 11, Annex 11, etc.)
Experience with pharmacopeia requirements (e.g. USP, JP, EP, etc.)
Experience in QC cGMP laboratory environment (analytical or microbiology)
knowledge of cGxP and regulatory requirements for clinical and commercial DP/DS
Strong expertise in Quality Control, including proficiency in analytical techniques and 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
Experience in analytical method transfer within a cGMP environment
Knowledge of aseptic DP process
Experience with lean six sigma/continuous improvement methodologies
Relevant certifications or training in quality management, GMP, or auditing are advantageous

Responsibilities

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, LIMS builds, 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 a Root 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 where quality representation is required; interface with R&D, QC, Operations, Engineering, Supply Chain, Technical Operations, Regulatory Affairs, as applicable
Support equipment lifecycle qualification activities
Escalate issues on time to management, as appropriate, and seek feedback in a timely manner
Perform and assist with additional duties as needed