Job Description

  Our client, one of the largest Pharmaceutical companies in USA is looking for Documentation Specialist role in West Point, PA. You should have strong Technical writing skills and managing SOP's .

Job Title: Documentation Specialist
Location: Onsite - 770 Sumneytown Pike, West Point, PA 19486

Must haves:
Writing specification protocols and Managing SOP's.
Raw material release for Jeff/SOP for Jennie
Strong Technical Writing Skills and Good manufacturing practices experience Documentum and SOP experience would be ideal candidate

Qualifications:
Required experience and skills:
Bachelor of Science or equivalent degree in a related field.
4+ yr. Experience
Strong Technical Writing Skills
Good manufacturing practices experience
Ability to manage projects/work to schedule/deadlines
Coherent Communication skills (no proof reading).
Good project management skills
Working knowledge of cGMP requirements
Demonstrated ability to manage multiple tasks and priorities
Effective verbal and written communication skills
Understanding of applicable regulations and guidelines governing clinical supply manufacture and release (CFR, ICH)
Must have strong communication, interpersonal, and organizational skills, including time management.
Candidate must have the ability to work independently on several projects maintaining critical timelines.

Responsibilities:
The Release and Critical Documentation Specialist will be responsible for the generation and review of documentation for the submission, testing, and release of raw materials, culture media/buffers, and excipients.
Primary responsibilities include release protocol development, preparing/maintaining appropriate critical GMP documentation.

Responsibilities also include:
Coordinate and maintain SOP review and approval process
Administering various functions within the Learning Management System (LMS)
Working with Subject Matter Experts, develop training requirements for Standard Operating Procedures, Analytical Procedures and other training material
Utilize templates for SOPs and supporting SOP documents

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –  Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.  

Job Tags

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