Documentation Specialist

7 days ago


West Point, Pennsylvania, United States Spectraforce Technologies Full time
Documentation Specialist

Location: West Point, PA 19486 (On-site initially; potential hybrid model after training - 3 days on-site, 2 days remote)

Duration: 1-year contract (potential for extension based on business needs and performance)

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

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