Job Details

  • Title: Documentation Specialist
  • Code: RCI-09338 / 09463
  • Location: Barceloneta Puerto Rico (PR) 00617
  • Posted Date: 09/09/2020
  • Duration: 5 Months
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  Job Description

Monday thru Friday 8hours shift

1st shift 8-5PM

Description:

Position Title: Documentation Specialist
Division: Global Pharmaceutical Operations
Department: QA Documentation Reporting

Special Responsibilities:

List essential responsibilities for the position in order of importance and priority for the job.

Describe the expected result for this position. Each must support the overall purpose of the position.
  • Verify the synchronization of changes in operational and documentation systems.
  • Maintain the folder of official copies controlled in the manufacturing areas.
  • Prepare manufacturing batches for execution.
  • Work in the retention area receiving the documents and entering them into the retention system.
  • Replace PCR's with the effective version and destroy the previous version of PCR's.
  • Prepare / Review manual PCR's to be used in the SVP (Small Volume Parenteral) area.
  • Provide assistance to operations in accordance with Environmental, Occupational Health and Safety (EH&S) management systems and promote continuous improvement.
Education

List the minimum requirements for education, skills, and necessary practical knowledge.
  • Associate Degree in Secretarial Sciences, Business Administration or Natural Sciences.
Experience:

Mention the minimum experience requirements necessary. Please include the titles
  • Experience in the area of documentation control - Minimum of two (2) years.
Work Environment
  • Social:
  • Physical:
  • conditions, frequency
  • Office Environment:
  • Continuously interacts with the different departments of the plant, eg. Validation, Training, Quality, Production, Engineering, IS, etc., at non-exempt staff levels up to the plant management and with Documentation representatives in Worcester and Division.
NOTES FROM INTAKE CALL

2 Positions

1) What hours and days will this person be working?
Monday thru Friday 8hours shift
1st shift 8-5PM
2) What are the top 5 skills / requirements this person is required have?
MS Word Proficient with advance experience
High level communication skills
Basic Excel
Fully Bilingual, candidate needs to read and correct documents
Experience in Documentation areas with experience change control
3) What years of experience, education, and / or certification are required?
Associate Degree in Secretarial Sciences, Business Administration or Natural Sciences.
Experience in the area of documentation control - Minimum of two (2) years.
GMP acknowledge / Experience

4) What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
5) What is the environment that this person will be working in (ie group setting vs individual role)?
Group Setting
6) Is any testing required for this role? NO
7) Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (ie 1 day remote, 4 days on-site)? On Site Role