Job Information
Actalent QA Associate in Clinton, Indiana
DESCRIPTION:
Responsible for the review and analysis of data supporting the quality of products/packaging, and ensures compliance with applicable procedures, cGMP's/standards and regulations.
RESPONSIBILITIES:
• Provide support to Quality systems.
• Organize, critically review, and present information in accordance with written procedures.
• Provide support for the production area.
• Apply/obtain statistical analysis.
• Write, review and revise GMP standard operating procedures.
• Track, maintain, and critically review and correct manufacturing records (tickets). Print additional documentation to include with manufacturing records for disposition.
• Maintain communication with QC lab regarding test results that are pertinent to batch release.
• Maintain communication with Supply Chain Representatives and to ensure batch manufacturing records are released in a timely manner.
• Approve raw materials for use in production areas. This includes
• Evaluating vendor COA’s
• Printing permits
• Approving materials as they arrive on site
• Blocking and unblocking material
• Tracking vendor information on a shared site for others to view
• Maintaining communication with MCO’s to ensure knowledge of materials received on site and materials needed urgently in production areas.
• Print and prepare batch manufacturing records as requested by Supply Chain. This includes
• Manually printing product shipping labels
• Verifying count and variable data information
• Tracking and creating additional labels as needed
• Maintaining communication with area ICO’s to ensure timely pick up and drop off of records and labels.
• Create or prepare Certificates of Analysis as requested by Customer Service Representatives. This includes
• Creation of AQIS documents and permits
• Updating Health and Non-Radiation Certifications
• Creation of Certificates of Manufacturing and Certificates of Conformity
• Tracking COA requests
• Creating of irregular COA’s and COA templates
• Mailing of documents to Customer Service Representatives
• Maintaining communication with Customer Service Representatives to ensure timely delivery of Certificates of Analysis to the country in need.
QUALIFICATIONS:
1) B.S/A.S Degree in related field OR no degree with 12+ months of QA/GMP experience
2) Demonstrate strong communication, documentation, and math skills
3) Proficiency with computers
4) Attention to detail lending to the ability to work well in a highly regulated environment
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.