Product Documentation Specialist

Miami, FL

Posted: 02/08/2019 Job Number: JN -022019-10459
Product Documentation Specialist-Pharmaceuticals

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Product Documentation Specialist
  • Location: Miami, FL
  • Industry: Pharmaceutical
  • Hours: Monday Friday, 8am-5pm
  • Salary: $45,000-$50,000
  • Employment Type: Permanent
Job Scope:
  • Responsible for Product Master Documentation; creating new Master Batch Records, and new revisions for current products.
  • Reviews and approve Master Batch Records made by the group.
  • Creates new Product Specifications for new products, and new revisions for current products.
  • Reviews and approve Product Specifications made by the group.
  • Reviews and approve Raw Material Specifications.
  • Makes Ingredient Lists
  • Makes allergen/MSMD statements
  • Creates required documentation for Reprocessing and Rework
  • Provides input to / review / approve Stability Protocols and Reports, IQ/OQ Protocols and Reports, Deviations, Investigation Reports, and SOP s
Skills Needed:
  • Three to Five years experience in R&D and/or GMP industry (pharmaceutical, nutraceutical, food/beverage is highly desired)
  • Worked in product development/formulation, product analysis, pharmacy setting, etc.
  • Should be highly organized and detail oriented
  • Good understanding of cGMP
  • Must be proficient in Word, Excel, and Internet research savvy
  • Able to read and write in English
  • Able to establish and maintain a positive and cooperative working relationship with members of supporting staff and inter-company departments
  • Able to multi-task
  • Able to follow routine verbal and/or written instructions
  • Able to work under pressure and meet deadlines
  • Able to effectively communicate in English written and oral
EDUCATION REQUIREMENTS:
  • Bachelor s Degree in scientific discipline

EOE/ADA

Search words: documentation, quality assurance, product review, master batch records, product specifications, formulation, technical services, ingredient list, manufacturing, GMP
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