Quality Specialist

2 weeks ago

Elkton VA United States Talent Software Services Full time

Quality Specialist - I

Job Summary: Talent Software Services is in search of a Quality Specialist for a contract position in Elkton, VA. The opportunity will be one year with a strong chance for a long-term extension.

Primary Responsibilities/Accountabilities: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.


Qualifications: 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: 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.


If this job is a match for your background, we would be honored to receive your application

Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk

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