Assistant Quality Specialist

Job Title: Assistant Quality Specialist
Job Location: Elkton, VA
Job Duration: 12+ months (Possibilities of Extension)
 
Shift Requirements: This will be a rotating shift role with the following hours: 6:30 am -3:30 pm and 1:30 pm - 10:30 pm. The successful candidate will support aseptic operations on rotating shift.

Description:
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 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.

 
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,MEDS, etc.
• Additional: Beta Lactam screening required for this role.

 
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