What are the responsibilities and job description for the Quality Specialist position at LanceSoft, Inc.?
Title: Quality Specialist
Location: Elkton, VA
Duration: 12 Months Assignment (Contract)
Pay: $35.00/ Hr to $38.00/ Hr based on experience.
Shift: 6:30 AM–3:30 PM and 1:30 PM–10:30 PM (Rotational)
Responsibilities:
- Perform various activities to support manufacturing operations while developing familiarity with site processes, procedures, and policies.
- Align individual knowledge and actions with 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 certification for Grade A/B gowning.
- May undertake quarantine functions and accountability reviews.
- Support special projects as assigned.
- Apply cGMP knowledge to make routine decisions and resolve quality and production needs.
- Follow site safety requirements.
- Author, review, and approve data/documents such as methods, procedures, and protocols.
- Complete assignments in a timely manner and actively participate in one or more teams.
- Track and report metrics as needed.
- Provide training and presentations when required.
- Assist with regulatory inspections.
Qualifications:
Minimum Education Requirement:
- Bachelor’s degree in Science, Health Science, Engineering, or a related discipline with 1–3 years of industry experience.
Required Experience and Skills:
- Previous experience in the pharmaceutical industry.
Preferred Experience and Skills:
- Prior experience supporting aseptic operations or sterile product manufacturing.
- Experience in Quality Assurance/Engineering roles or technical positions.
- Background in food or pharmaceutical environments, particularly in regulatory/inspection roles.
- Proficiency in project management and process data analysis.
- Lean Six Sigma Certification.
- Familiarity with systems such as SAP and MEDS.
Additional Requirements:
- Beta Lactam screening is required for this role.
Shift Requirements:
This role involves rotating shifts with the following hours:
- 6:30 AM–3:30 PM and 1:30 PM–10:30 PM
The successful candidate will support aseptic operations during these rotating shifts.
Salary : $35 - $38
