Job Description
Job Title: Quality Assurance Specialist Job Description •Review 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 the status of batches to ensure all QA batch disposition deadlines are met.
•Review analytical reports to ensure that products, materials, components, and intermediates meet company standards and regulatory requirements.
•Review all test results generated in support of testing of raw materials, in-process, finished products, 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 in-house monographs and USP and other compendia in a regulated laboratory environment.
•Review environmental monitoring data, microbiology, and cleaning testing results.
•Review quality events, incidents, and deviations related to manufacturing processes and 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, and create and revise relevant SOPs.
Hard Skills - Documentation Control
- GDP
- Batch Record
Soft Skills - Effective Communication
- Attention to Detail
- Problem Solving
- Collaboration
- Initiative
Job Type This is a contract position with a duration of 6 Month(s).
Work Site This is a fully on-site position in Coral Springs, Florida.
Work Environment Lab Environment; FDA and GMP regulated. Clean room. Hours: 1x 2nd shift 2pm - 10pm, 1x 3rd shift 10pm - 6am
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 for other accommodation options.
Job Tags
Contract work, Night shift, Afternoon shift,