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QA Associate
Ref No.: 18-02673
Location: Durham, North Carolina
Position Type:Direct Placement
Experience Level: 3 Years
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract QA Associate
Duration: Possible Temp to Perm
Client Location:  Durham, NC
Work Schedule:  40 Hours Weekly
Pay Rate:  Based on expereince
Benefits: ACA Compliant Medical Insurance

*****LOCAL CANDIDATES ONLY

JOB SUMMARY

QA Associate is to perform all required in-process testing & sampling for Manufacturing and Packaging batches. Perform incoming inspections and outgoing inspections of finished product batches. Perform verifications using special instruments (Caliper, Balance, etc.) to assign final approval to Labeling, Packaging and Raw Materials.
  • Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.
  • Complete all applicable training forms in a timely manner and forward to document control for archival
  • Data Entry of Finished Product Information into the APR (Annual Product Review) system
DUTIES & ESSENTIAL JOB FUNCTIONS
  • Perform all required in-process testing & sampling of batches in progress and products to be packaged.
  • Perform line clearances of the manufacturing/ packaging areas and equipment
  • Verify and confirm issuances and reconciliation of product and components
  • Performing Cleaning Verification/Validation swabbing of equipment
  • Verify that temperature/humidity, D.I. Water and Magnehelics are all in range and good working condition
  • Handle various requests from departments for developmental or investigative reasons
  • Capture critical information for Customer Complaint/Deviation investigations/CAPA/Change Controls (when necessary)      
  • Review and Approve Preventive Maintenance or Work Orders; (if necessary)
  • Participate in Stability/Validation product Sampling
OTHER FUNCTIONS AND RESPONSIBILITIES
  • Preparation and issuance of the BMR, BPR, validation protocol, validation report, SOP’s
  • Collection and inventorying of Retain and/ or Stability Samples
  • Review of equipment, machine, area qualifications
  • Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)
  • Replace Temperature/Humidity Charts weekly
  • Maintaining IPQA supply inventory
QUALIFICATIONS
  • High School Diploma with some college courses or Associates Degree
  • Experienced in proper documentation and correction practices
  • Read, write and speak English
REQUIRED
  • 2-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment
  • Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals
  • Be able to work long hours to support production requirements as needed
  • Be available for overtime, including weekends, as needed for production support
  • Possess the ability to analyze information and make consistently good decisions
REQUIRED LICENSES/CERTIFICATIONS
  • A familiarity with cGMPS, CFRs, OSHA and FDA regulations
  • Experience with deviations/incidents and CAPA
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
  • Stand/walk for the majority of the shift.
  • Must be able to bend at the waist and knees as well as twist at the trunk.
  • Must practice good personal hygiene
  • Must be able to lift up to 30 lbs.
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-02673 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).

**Candidates must complete background and drug screenings before starting any assignment.

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.