Actalent

Our client, a global bio-pharmaceutical manufacturing organization is seeking a motivated Documentation Specialist to join the quality team. Day to day this individual will prepare and review required documentation for the QC lab, implement change control processes using the Global Quality Tracking System (QTS) and PDOCs, coordinate the review and revision of procedures, specifications, and forms.

Responsibilities:

• Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
• Follows procedures at all times, adopting cGMP, cGDP practices.
• Edit and Write Standard Operating Procedures and other documentation as needed
• Initiate and facilitate change requests in PDOCS and the Global Quality Tracking System (QTS)
• Reconcile change requests from initiation to closure
• Review and approve documents in the change control system

Additional Skills & Qualifications:

• Bachelor’s degree with 1 to 2 years’ experience in a controlled document management/records management position required.
• Technical writing experience from industry or academia is required
• Thorough knowledge of cGMP and cGDP
• Proficient in Microsoft Office (Word, Excel, Powerpoint)
• Ability to work independently and multi-task in a fast, priority – switching environment while demonstrating a positive attitude
• Strong attention to detail and excellent written and verbal communication skills
• Strong reading comprehension and proof reading skills, strong organizational skills
• Demonstrated ability to work/contribute in a team-based environment
• Team and customer oriented
• Ability to facilitate process improvements

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 for other accommodation options.