Documentation Specialist II

Primary Talent Partners has a 12 month contract opening for a Documentation Specialist to join a multinational pharmaceutical company for an onsite position operating out of West Point, PA. 

Pay: $31.00/hr - $36.00/hr
Contract: 12 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship

Summary:
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:

• 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

Required Qualifications:

• 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.
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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