Be an early applicantLess than 25 applicants

This job has closed.

Company

Original Job Post

BioSpace · 2 days ago

Quality Assurance Area Specialist

Clayton, NC

Full-time

Onsite

Mid Level

4+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyCommunities

Comp. & Benefits

Insider Connection @BioSpace

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs

Review & approve documentation for Quality approval – components/raw material, batch records, change control requests, deviations, Quality Control (QC) laboratory investigations, SOPs & validation documents

Participate in project teams as a quality resource

Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement techniques

Participate in process confirmations & Go Look Sees

Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports

Follow all safety & environmental requirements in the performance of duties

Other accountabilities, as assigned

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

QA experiencePharmaceutical industryMedical device industryAuditingSix SigmaLEAN toolsMS OfficeMS ProjectPowerPointProblem-solvingHard-workingCommunicationGoal-settingTime-managementAdaptabilityQuality SystemsRisk AssessmentRisk ManagementCritical ControlsProject ManagementSupplier ManagementNNPILP ProcessesQuality ControlAseptic ProductionBusiness SupportQCFacilitiesWarehousingLogisticsO&P

Required

High School Diploma (GED) required

Minimum of four (4) years of QA and/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility required

Excellent written & verbal communication skills required

Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

Auditing experience with certification required

Experience in the use of Six Sigma & LEAN tools required

Sets goals & prioritizes tasks for own work on short-term basis required

Meets deadlines & makes regular progress reports on performance required

Keeps track & informs management about fluctuation in workload required

Performs well with multi-tasking required

Adjust priorities in accordance with changing circumstances required

Preferred

Bachelor’s degree in Life Sciences or a relevant field of study from an accredited university preferred

General knowledge of regulations & quality systems (e.g., product disposition, deviations, Change Control, Audits, Supplier Management, Project Management, etc.) preferred

Familiarity with local processes & quality systems preferred

Familiarity with risk assessment/risk management preferred

Demonstrated knowledge of critical controls & input/output requirements for NNPILP processes preferred

Knowledge of Quality, and /or Aseptic Production, Business Support, QC, IT, Facilities/Utilities, warehousing/logistics, O&P, and Finished Production processes preferred

Knowledge of US, EU regulations & guidelines, ISO standards & application of Good Manufacturing Practices (GMPs) preferred