Quality Specialist Jobs

Job Title: Quality Specialist

Location: Elkton, VA

Job Type: Contract Role

Job Details:

Qualifications

Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience. Required Experience and Skills: Previous Experience in the pharmaceutical industry. Preferred Experience and Skills: 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.

Responsibilities

• May provide training/ presentations as needed.
• May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements.
• The individual tracks/reports metrics as needed.
• Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols.
• May help with regulatory inspections.
• 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.
• The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
• Supports special projects as assigned.
• 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.
• Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.

Position may require shift work 2-3 times per year, for a period of 5 days. Must be flexible to accommodate this need.