Process Scientist – Arecibo, PR

SUMMARY

Assist   the   Production Leader    in   assuring that Operational area   complies    with quality, safety, environmental policies, guidelines, Standard Operational Procedures (SOPs) and other standards. Responsible in the development and implementation of Quality, Safety and Environmental objectives for the Operational area. Support the inventory control activities for the Operational area.

RESPONSIBILITIES

  1. Support the Operational area in the review and/ or preparation of SOPs and forms  to assure  that they comply  with the CFR 211 and applicable guidelines in the areas  of quality, safety  and  environmental. Generates new specifications. changes or instructions, as needed. Develop and implement sampling plans for the production processes.  Support the Process Leader in technical and/ or process evaluations as needed.
  2. Coordinate activities that are part of the investigation process, assigning related tasks to other support members. Perform Quality Notifications and accountable for making sure that root causes are properly identified and documented. Assist in the determination of the quality impact of an event. Identify and analyze trends, using  statistical  and/ or  quality tools  as  needed.  Responsible for ensuring proper identification and implementation of corrective and preventive actions.  Follow-up for the completion of preventive actions.   Responsible to maintain USP waster sampling program in the manufacturing area.
  3. Responsible for the plan and  coordination of regulatory compliance and  safety  proactive programs to create  proficiency  in  safe  work  practices   and  promote safety  awareness among support  members.
  4. Assist in the appropriate determination of safety equipment and  safe work  practices.   Provides advice and   assistance  in  the   evaluation  of  safety   and   environmental  opportunities  and   recommends appropriate  actions.   Perform S&E self-audits  and  inspections;  track  closure  of  recommendations. Support the Operational area in ensuring compliance with environmental regulations and  procedures as applicable.  Provide training and orientation as needed.
  5. Responsible  for  reviewing  the  production  processes  [i.e.   manufacturing,   packaging)   to  assure adherence to current Good Manufacturing Procedures (cGMP’s), MPDs (Manufacturing Process Description). SOPs and OSHA regulations. Perform  self-assessments, as needed, in the areas of quality, compliance and  safety.  Prepare the responses for internal audits  and  develop  action plans  as needed. Coordinates and  evaluate any data trend  as results of CPV (Continuous Process  Verification)  or APR (Annual Product Review)  as needed.
  6. Support the Operational area  by developing and  providing technical  training and  in  areas  related  to quality  and regulatory compliance, including but not limited to quality  matters, sampling plans, safety, human behavior, documentation trends  and environmental.
  7. Willing to work irregular and/ or rotating shifts.
  8. Support the inventory control activities, assuring that adjustments  in quantity and/ or investigations related to out-off limit accountability are done  as needed. Assure  that material reconciliation is done against SAP; that transactions are performed and  Work-Orders are closed.
  9. Accountable for the compliance with cGMP’s,  Safety, Health, Environmental, Local and Federal  Labor, and Industrial regulations.
  10. Mentors    members under   his/her   supervision,   provides  input  and   coaching    on   professional development and  career path; provides timely  feedback,  evaluates performance of direct reports after obtaining the relevant functional input and evaluation.
  11. Perform   any  other  job  related  duties   as  required  or  that may  arise  in  the  future  such  as  support technology transfer,  process  development and launches.
  12. Comply  with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and  internal notifications of any environmental event.
  13. Perform  any other job related duties  as required or that may arise in the future.

Education and/ or Experience

  • Bachelor Degree  in Science, Pharmacy or Engineering.
  • Minimum of 3 years of production, quality or compliance experience in a highly  regulated manufacturing environment, such as pharmaceutical and/ or medical  devices.