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Description:
This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling coordination and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.
Primary Responsibilities of the Role Include:
Inspect materials including biobags tubing filters and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
Remove samples from containers of medias and other chemicals to facilitate the testing of samples
Use RAMAN technology with TruScan equipment to identify chemicals
Ensure that inspection sampling results are complete and detailed according to written procedures and cGMP requirements
Responsible for accurately documenting inspection sample and test results in software systems
Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
Ability to determine the color of components match required attributes
Support inspection readiness activities including site audits and inspections
Maintains project plan commitments supporting critical projects
Supports Continual Improvement initiatives programs and projects
Serve as a shift lead in the raw material inspection and sampling areas
Assist area management with the prioritization and scheduling of tasks
Serve as a trainer and subject matter expert in tasks associated with raw material inspections samples and testing
Own controlled documents for the area including SOPs and FORMs
Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections samples and testing areas
Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.
Experience with raw material disposition is preferred.
Additional Skills & Qualifications:
-High school/GED + 4 years (Job Code Discipline and OR Sub-Discipline) work experience OR
?-Associate + 2 years (Job Code Discipline and OR Sub-Discipline) work experience OR
?-Bachelor + 6 months (Job Code Discipline and OR Sub-Discipline) work experience?-Master  ?
Strong understanding of cGMP regulations and GDP requirements and experience with SAP, LIMS and Trackwise.
Experience with RAMAN, TruScan, and drafting and creating an SOP.
Experience in raw material inspections, sampling, and testing
A minimum of 2+ years of relevant working 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 for other accommodation options.
