What are the responsibilities and job description for the Quality Specialist position at Careers Integrated Resources Inc?
Job Title: Quality Specialist
Location: Elkton, VA
Job Duration: 12 months
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.
Job Description
Education Minimum Requirement:
Bachelor’s degree in science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.
Required Experience and Skills:
Preferred Experience and Skills:
Location: Elkton, VA
Job Duration: 12 months
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.
Job 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 as 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.
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.
