Job Description

In-Process Quality Assurance (IPQA) SpecialistThe In-Process Quality Assurance (IPQA) Specialist provides real-time quality oversight for sterile injectable manufacturing operations, ensuring that all activities comply with current Good Manufacturing Practices (cGMP), approved procedures, regulatory requirements, and internal quality standards. This role focuses on shop-floor quality assurance, including in-process inspections, batch record review, deviation investigations, and aseptic processing oversight, to support the consistent production of safe, high-quality sterile pharmaceutical products.ResponsibilitiesProvide real-time quality oversight across sterile injectable manufacturing operations, ensuring strict adherence to cGMP, Standard Operating Procedures (SOPs), and approved Batch Manufacturing Records (BMRs).Perform routine in-process quality inspections on the manufacturing floor to verify that production activities meet defined quality standards and specifications.Provide quality assurance oversight during material dispensing, ensuring correct materials, quantities, and labeling are used according to approved documentation.Oversee compounding activities to confirm compliance with procedures, correct sequencing of steps, and accurate documentation of process parameters.Monitor sterile filtration operations to ensure filters, equipment, and processes meet validated requirements and are documented appropriately.Provide QA oversight during aseptic filling operations, verifying adherence to aseptic techniques, environmental controls, and process parameters.Oversee vial or container sealing and capping operations to ensure container closure integrity and compliance with defined specifications.Support lyophilization activities by verifying equipment readiness, cycle parameters, and documentation of critical steps.Monitor visual inspection activities for filled and finished product to ensure defects are identified, classified, and documented according to procedures.Provide QA oversight during packaging operations, confirming correct components, labels, and coding are used and documented accurately.Conduct line clearance activities prior to manufacturing and packaging processes to ensure removal of previous materials, components, and documents, preventing mix-ups and cross-contamination.Verify equipment cleanliness, calibration status, and readiness for use before production, ensuring all equipment meets qualification and maintenance requirements.Perform in-process sampling according to established procedures and verify that samples are collected, labeled, and handled in compliance with quality and regulatory expectations.Monitor critical process parameters during manufacturing and confirm that operations remain within approved specifications, escalating issues when deviations occur.Review manufacturing documentation, logbooks, and production records for accuracy, completeness, and regulatory compliance, identifying and correcting gaps or errors.Verify material, equipment, and status labeling throughout production to ensure accurate identification and traceability at all stages of manufacturing.Review executed Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs) for completeness, correctness, and compliance prior to batch disposition.Assist with batch disposition and release activities by providing quality input, supporting documentation review, and confirming resolution of quality events.Conduct audit trail reviews for manufacturing equipment and computerized systems to ensure data integrity and compliance with internal and regulatory expectations.Identify, document, and escalate deviations, nonconformances, and quality events observed during manufacturing and packaging activities.Support investigations related to deviations, out-of-specification (OOS) results, and manufacturing events by gathering data, reviewing records, and contributing to root cause analysis.Participate in the development and implementation of Corrective and Preventive Actions (CAPA) to address identified root causes and prevent recurrence of quality issues.Ensure consistent adherence to Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+) across all manufacturing and quality records.Verify that environmental monitoring activities are performed according to schedule and that results are reviewed and addressed as needed.Ensure compliance with aseptic techniques and gowning procedures, reinforcing best practices and intervening when noncompliance is observed.Support media fills, validation activities, engineering batches, and equipment qualifications by providing quality oversight and ensuring documentation aligns with regulatory expectations.Participate in internal audits, customer audits, and regulatory inspections by providing information, documentation, and on-the-floor support as needed.Promote a culture of quality, compliance, and continuous improvement within manufacturing operations by collaborating with cross-functional teams and modeling quality-focused behaviors.Essential SkillsBachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or another Life Sciences discipline.At least 5 years of Quality Assurance or In-Process Quality Assurance experience within a pharmaceutical manufacturing environment.Direct experience supporting sterile injectable manufacturing operations.Extensive experience in shop-floor quality assurance, including in-process inspections and real-time oversight of manufacturing activities.Strong understanding of aseptic processing principles and sterile manufacturing regulations.Proficiency in reviewing Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs) for accuracy and compliance.Hands-on experience with batch record review and document control in a regulated pharmaceutical setting.Knowledge of current Good Manufacturing Practices (cGMP) and their application in sterile manufacturing.Familiarity with sterile filtration and lyophilization processes within pharmaceutical production.Experience performing and overseeing line clearance activities in manufacturing and packaging areas.Ability to identify, document, and escalate deviations, nonconformances, and quality events in a timely manner.Experience supporting investigations for deviations, out-of-specification (OOS) results, and manufacturing events.Understanding of Corrective and Preventive Action (CAPA) management and root cause analysis methodologies.Strong attention to detail and ability to detect documentation errors, process anomalies, and compliance gaps.Effective problem-solving skills with the ability to analyze complex manufacturing and quality issues.Strong communication skills with the ability to collaborate effectively with manufacturing, quality, and support functions.Commitment to Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+).Additional Skills & QualificationsKnowledge of FDA 21 CFR Parts 210 and 211 and their application to sterile pharmaceutical manufacturing.Familiarity with EU GMP Annex 1 requirements for sterile medicinal products.Experience with aseptic manufacturing practices, including gowning, aseptic behaviors, and cleanroom discipline.Exposure to environmental monitoring programs and interpretation of environmental data.Experience performing or overseeing visual inspection of sterile products.Knowledge of line clearance procedures and their role in preventing mix-ups and cross-contamination.Experience conducting audit trail reviews for manufacturing equipment and computerized systems.Understanding of Data Integrity principles (ALCOA+) and their implementation in a GMP environment.Experience participating in internal audits, customer audits, and regulatory inspections.Strong organizational skills and ability to manage multiple tasks and priorities in a fast-paced manufacturing environment.Demonstrated ability to promote a culture of quality, compliance, and continuous improvement.Work EnvironmentThe role is based in a highly regulated Good Manufacturing Practice (GMP) environment focused on sterile injectable pharmaceutical production. Work is primarily performed in cleanroom areas, including classified manufacturing suites where aseptic processing, sterile filtration, filling, lyophilization, visual inspection, and packaging operations take place. The position requires adherence to strict cleanroom protocols, including appropriate gowning and aseptic techniques, as well as compliance with environmental monitoring and facility procedures. The IPQA Specialist works closely with manufacturing, quality, and support teams on the production floor, providing real-time oversight and guidance in a dynamic, operations-driven setting that emphasizes operational excellence, regulatory compliance, and continuous improvement.Job Type & LocationThis is a Contract to Hire position based out of Deerfield Beach, FL.Pay and BenefitsThe pay range for this position is $36.06 - $46.67/hr.Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision •

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