Quality Assurance Specialist
6 days ago
Irvine
Job Description Job Title: Quality Assurance Specialist Job Description The Quality Assurance Specialist ensures the accuracy, completeness, and compliance of batch records and associated quality documentation for pharmaceutical or medical device products. This role focuses on reviewing both electronic and paper batch records, verifying manufacturing processes and data against established procedures and specifications, and supporting the overall Quality System to maintain product safety and regulatory compliance. Responsibilities • Review approximately three batch records per day, including both electronic and paper records, with a strong emphasis on accuracy and completeness over volume., • Evaluate batch records for compliance with operating procedures, specifications, and Good Manufacturing Practice (GMP) requirements., • Review data and manufacturing process verifications to ensure alignment with approved procedures and quality standards., • Organize and review in-process control samples and ensure they are properly prepared and transferred according to established processes., • Provide support for quality activities, including initiating and compiling supporting data to help resolve quality issues., • Provide quality oversight over the Quality System, including the review of reports, data (including metadata), and records generated to support the manufacturing and distribution of product., • Conduct timely quality review of associated data, including data used to support batch release, to meet business and operational timelines., • Assist in complying with regulatory requirements related to product safety and quality, including relevant FDA and ICH guidelines and standard methods., • Ensure that procedures are followed as outlined under FDA, ICH, standard methods, and internal Quality System requirements., • Review records to confirm that data meets industry requirements for data integrity., • Collaborate with cross-functional teams, including microbiology and chemistry, by reviewing their data and documentation for accuracy and compliance., • Apply sound judgment under general supervision to identify, escalate, and help resolve quality-related issues., • Ask clarifying questions and proactively seek information to resolve discrepancies or uncertainties in batch records and quality documentation., • Maintain a high level of organization and attention to detail in a fast-paced and sometimes stressful environment., • At least 2–3 years of hands-on batch record reviewing experience, with emphasis on depth and quality of experience over high-volume processing., • Bachelor’s degree in a Science discipline., • 5–6 years of overall experience in a quality assurance, pharmaceutical, medical device, or related regulated environment., • Demonstrated experience in quality assurance and document control within a GMP setting., • Proven ability to review batch records, including verification of data, calculations, and signatures for completeness and compliance., • Strong attention to detail and accuracy when handling critical quality and manufacturing data., • Excellent communication skills, both written and verbal, to clearly document findings and collaborate with cross-functional teams., • Strong critical thinking and problem-solving skills to identify issues and support corrective actions., • Ability to work under general supervision while using sound judgment to resolve routine issues., • Confidence to ask questions, seek clarification, and work independently when appropriate., • Ability to handle a fast-paced and sometimes stressful work environment while maintaining high quality standards., • Experience with Labware in a GMP environment, particularly for batch record reviewing and reviewing microbiology and chemistry data, is highly desirable., • Experience with Manufacturing Execution Systems (MES) and other electronic systems used for batch documentation and data review is a plus., • Experience in the medical device or pharmaceutical industry, particularly in sterile products such as saline and syringes, is beneficial., • Familiarity with FDA and ICH guidelines, standard methods, and industry expectations for data integrity., • Experience supporting corrective action plans, validation activities, and other quality system processes is an advantage., • Strong organizational skills to manage multiple batch reviews and documentation tasks effectively. This is an on-site role in a dynamic, fast-paced environment that supports the manufacture of sterile medical products for use in hospitals and clinics. The position typically follows a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m., with some flexibility, as some team members start as early as 5:30 a.m. The broader operation runs on extended schedules, and there may be occasional need for flexibility, weekend coverage, or on-call support as business needs arise. The work is performed in a regulated GMP and medical device/pharmaceutical production environment, with close adherence to documented procedures, data integrity standards, and regulatory requirements. You will work primarily with electronic systems and paper records for batch documentation, as well as quality systems tools such as Labware and MES where applicable. The culture emphasizes quality, compliance, reliability, and teamwork, and offers medical, dental, and vision benefits along with holiday, paid time off, and sick pay. Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $43.00 - $43.00/hr. 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, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.