Quality Specialist

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