Quality Specialist - I - Planet Pharma : Job Details

Quality Specialist - I (Assistant)

Location: Elkton, VA

Contract Duration: 12 Months

Target Pay Rate: $35.00 - $39.92 per hour

Additional Requirements:

• Beta Lactam screening required.
• Rotating shift schedule: 6:30 AM - 3:30 PM & 1:30 PM - 10:30 PM.

Job Overview:

The Quality Specialist I (Assistant) will provide essential support to manufacturing operations by gaining familiarity with site processes, procedures, and policies while developing expertise aligned with cGMP (current Good Manufacturing Practices) and Health Authority regulations.

Key Responsibilities:

• Assist in the review and approval of key quality documents such as qualification activities, change controls, batch records, investigations, and other quality-related paperwork.
• Support aseptic operations on shift, including auditing classified (Grades A/B/C) areas and achieving certification for Grade A/B gowning.
• Potentially perform quarantine functions and conduct accountability reviews.
• Support and contribute to special projects as needed.
• Make informed decisions based on cGMP knowledge and processes.
• Work with internal and external stakeholders to resolve quality and production issues.
• Adhere to site safety requirements and participate actively in safety initiatives.
• Write, review, and approve methods, procedures, and protocols.
• Complete tasks and assignments on time, contributing effectively as a team member.
• Track and report metrics as required.
• Provide training or presentations as needed.
• Assist in regulatory inspections when required.

Qualifications:

Education:

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

Required Experience and Skills:

• Previous experience within the pharmaceutical industry.

Preferred Experience and Skills:

• Experience supporting aseptic operations or working with sterile products.
• Background in Quality Assurance, Engineering, or a Technical role.
• Experience in regulatory/inspection roles within the pharmaceutical or food industry.
• Project management experience and data analysis skills.
• Lean Six Sigma Certification.
• Familiarity with SAP, MEDS, or similar systems.