Interested in working for a growing Pharmaceutical company? Apply to work for Merck in Elkton, VA!
This role is in the Quality group. It involves reviews and approvals of batch records, change controls, quality deviations, procedures, and other related documents.
This is a fantastic opportunity to break in to bulk manufacturing and get real industry experience. This is a full time contract job.
· The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
· The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures and other quality related documentation. The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning.
· May perform quarantine functions and accountability reviews.
· Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
· May work with customers to resolve problems and to satisfy quality and production needs.
· Follows site safety requirements. Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
· Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
· The individual tracks/reports metrics as needed.
· May provide training/ presentations as needed.
· May help with regulatory inspections.
Education Minimum Requirement:
Bachelor’s Degree in Science, Health Science, Engineering, or related discipline.
Preferred Experience and Skills:
· Previous Experience in the pharmaceutical industry.
· Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance/Engineering role or Technical role. Previous experience in food or pharmaceutical environment in regulatory/inspection role. Previous experience in project management, process data analysis.
· Lean Six Sigma Certification
· Previous Experience with SAP, Midas, or Trackwise