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Description: Review of executed batch records and all related documentation for manufacturing activities in accordance with good documentation practices (GDP), product specifications, process parameters and regulatory requirements. Communicate effectively with cross functional departments to ensure on time delivery of corrections, QA review and disposition responsibilities. Compile and review all applicable documentation for batch review and release, keep track and oversee status of batches to ensure all QA batch disposition deadlines are met. Review of analytical reports to ensure that products, material, components and intermediates meet company standards and regulatory requirements. Review all tests results, generated in support of testing of raw materials, in-process, finished product and stability samples including, but not limited to, assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to the in-house monographs and USP and other compendia in a regulated laboratory environment. Review of environmental monitoring data, microbiology and cleaning testing results. Review of Quality events, incidents and deviations related to manufacturing processes, and to Laboratory testing, OOS, OOT, and OOE investigations. Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Provide the required support during regulatory and internal audits. Keep track of data and records review indicators for internal quality metrics and annual product review. Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, create and revise relevant SOPs.Additional Skills & Qualifications:
Bachelor’s degree in Life Sciences discipline.
1 year experience in a Quality Assurance/Quality Control or Manufacturing function within cGMP Biotech or Pharma environment
1+ year batch record and analytical data review experience required.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
