Job Title: Quality Specialist - I
Location: Elkton, VA 22827
Duration: 12 Months Contract
Pay Rate: $30 - $40 Hr. on W2
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. Shift Requirements: This will be a rotating shift role with the following hours: 6:30a-3:30p and 1:30p-10:30p. 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.
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
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