Job Details

  • Title: QA Specialist - I
  • Code: RCI-03122
  • Location: Barceloneta, PR 00617
  • Posted Date: 12/03/2021
  • Duration: 12 Months

  Job Description

Monday to Friday 8-5PM, but candidate must be available for any special shift , work Saturday or weekend based in busines needs.

QA Technical Specialist

Job Description:
  • Act as contact person for projects as required.
  • Generate lot lists for the Product Quality Review.
  • Assemble the batch record review package and label per the approved retention procedures.
  • Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product.
  • Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.
  • Evaluate all deviations documented in batch records and determine the need for a corrective action.
  • Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).
  • Audit finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
  • Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.
  • Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.
  • Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.
  • Enter required batch information into the lot restriction management system.
  • Prepare reports including Right the First Time, Release Cycle Time and the delay reports.
  • Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.
  • Demonstrates accountability and responsibility of EHS performance and compliance.
Knowledge/ Education Required:List

the minimum education, skills, requirements, practical knowledge, etc., needed to qualify.
  • Bachelor’s Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
  • Knowledge and experience in manufacturing of biotechnology products and GMPs is needed.
Experience Required:List

the minimum experience needed to qualify. Please include the position titles or descriptions of experience and required years.
  • Experience working in highly computerized Operations environments– 1 Year
  • Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing or quality – 2 Years
  • Total combined minimum years of experience 2 years. (Not necessarily the sum of the above)
Quality, Safety & Environmental Responsibilities:Working

conditions, frequency.
  • Will need to work in an office environment in which computer communication through E-mail and information will take about 90% of the working time. Will need to read and review a
  • considerable amount of documents during the normal day.
  • No exposure to noise, dust, toxic or dirt.
  • Routine interaction with QC, QA, Production, Materials, Validation and Documentation departments.
  • Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.
Intake Notes

• Are you open to look at candidates willing to relocate? ? Note Virtual Interview process to be followed.
• Years of experience/education and/or certifcations required:
· Bachelor’s Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.
· Knowledge and experience in manufacturing of biotechnology products and GMPs is needed.
Experience Required:List
the minimum experience needed to qualify. Please include the position titles or descriptions of experience and
required years.
· Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing or quality – 2 Years
· Experience working in highly computerized Operations environments– 1 Year
· Total combined minimum years of experience 2 years.
(Not necessarily the sum of the above)
• What are the top 3-5 skills requirements should this person have?

1: Experienced in parenteral manufacturing / Fully Billingual
2: GMP acknowledge, Data integrity
3: Ability to independently audit documentation/ batch records electronic and paper documentation
4: Review Manufacturing documentation before lots release
5: Able to audit and review deviations and discrepancies and recommend any corrective action needed

• What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Previous experience in electronic batch records; MES, SAP systems

• What type of environment is this person working in?

o Combination of group setting and individual setting

• Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?
Monday to Friday 8-5PM, but candidate must be available for any special shift , work Saturday or weekend based in busines needs.

 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 (i.e. 1 day remote, 4 days on-site)? On Site