Quality Specialist - AgileOne : Job Details

Position: Quality Specialist - I (Assistant)

Location: Elkton, VA

Pay Rate: $35-39/HR

Responsibilities:

• Support manufacturing operations by becoming familiar with site processes, procedures, and policies.
• Develop knowledge of cGMPs and Health Authority regulations.
• Review and approve qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality-related documentation.
• Support aseptic operations on shift, including auditing classified areas (Grades A/B/C) and obtaining certification for Grade A/B gowning.
• Perform quarantine functions and accountability reviews.
• Assist with special projects as assigned.
• Make decisions based on cGMP and process knowledge.
• Resolve quality and production issues in collaboration with customers.
• Adhere to site safety requirements.
• Author, review, and approve data/documents such as methods, procedures, and protocols.
• Complete assignments in a timely manner and contribute as an active member of one or more teams.
• Track and report relevant metrics as needed.
• Provide training and presentations as required.
• Assist with regulatory inspections as needed.

Qualifications:

Education Minimum Requirement:

• Bachelor's degree in Science, Health Science, Engineering, or related discipline with 1-3 years of industry experience.

Required Experience and Skills:

• Previous experience in the pharmaceutical industry.

Preferred Experience and Skills:

• Experience supporting aseptic operations or sterile products.
• Background in Quality Assurance/Engineering or a Technical role.
• Previous experience in food or pharmaceutical regulatory/inspection roles.
• Familiarity with project management and process data analysis.
• Lean Six Sigma Certification.
• Previous experience with SAP, MEDS, etc.
• Additional: Beta Lactam screening required for this role.

Shift Requirements:

This is a rotating shift position with the following hours:

• 6:30 AM - 3:30 PM
• 1:30 PM - 10:30 PM