Campus Pride Jobs

Quality Specialist Elkton, VA 22827 12 months Shift Requirements: This will be a rotating shift role with the following hours: 6:30a-3:30p and 1:30p-10:30p.

Qualifications: 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.
• The successful candidate will support aseptic operations on rotating shift.

Responsibilities:

• 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.

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.