Jobs for People with MS: National MS Society

Actalent is Hiring a QA Associate

(Clinton, IN)

Description:

Job 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.

Job Duties:

• 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.

• Perform inbound Quality Analysis and receipt for printed packaging materials. Approve printed packaging materials for use in production areas.

• Monitor temperature records of bulk material received for Companion Animal Products.

• Approve bulk material received for Companion Animal Products.

• Own, track, and route documents in Veeva Vault for edit, review, and approval as needed for Quality Assurance Representatives and Technical Service/Manufacturing Science Representatives.

Skills:

Quality Assurance, Batch Record, GMP, pharmaceutical, Life Science, Quality Inspect, Titration, Quality Documentation, pH Test, Analytical, Biology, Chemistry, Batch Record Review, COA, Laboratory, QA Test, QA Check, QA Documentation, SOP Review

Additional Skills & Qualifications:

Must Haves:

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

Nice to Have:

1) Batch Record Review

Experience Level:

Intermediate Level

SCHEDULING INTERVIEWS ASAP

• Reach out directly and apply to Sydney Brooks to be immediately in consideration for our current opportunities with your updated resume, a brief intro about you and your skills, and what method of communication works best for you (i.e., call, email, text)

• DIRECT LINE: 317- 567-6625

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.