Description:

Responsible for establishing and maintaining accurate, current files on all related documents, literatures and materials. Manage change control program by issuing change control number, collecting and routing change documents to stakeholders and maintaining change control log. Manage training matrix, scanning and filing training records. Prepare documents (certificate of analysis, master dossier, specifications, procedures, methods, forms, etc.) in an approved format for signatories. Documents may include highly confidential information which should be treated accordingly. Responsible for issuing accurate, error free written documents. Audit and prepare monthly reports on the Cost of Quality (OOS, NCR’s, CAPA, Return Goods, Customer Complaints, Yield Discrepancies, Labeling Discrepancies, Hold Items) Track outside testing reports and billing. May do research for a project or a specific matter May receive visits or calls regarding complaints, customer comments and instructions which may be resolved or referred to the appropriate person. Organize and expedite work flow through department head’s office. Keep department head(s) update with day’s event and occurrences. Manage projects and daily required testing to outside labs, as well as ongoing follow up to ensure timely response for results Perform other duties as assigned by Supervisor and/or Head of Quality and Regulatory Affairs Retrieves information from the computer system as requested Respond quickly to requests for technical information and to problems as needed Track and manage SOP’s review/revision as required

Skills:

Chemistry, Hplc, Qc, Laboratory, Quality control, Analytical chemistry, Gmp

Top Skills Details:

Chemistry,Hplc,Qc

Additional Skills & Qualifications:

An associate degree or higher in computer science, business administration or related fields 3+ years of experience in Document Control in a GMP environment CAPA Experience Ability to work in fast-paced environment

Experience Level:

Intermediate Level

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.