Quality Control Coordinator (Durham)

Job Title: Quality Control Coordinator

Location: Durham, NC

Duration: 07 months

Pay Range: $(27.00 – 30.00)/hr on W2 all-inclusive without benefits

Shift Schedule: Monday – Friday (7 am – 4 pm or 8 am – 5 pm EST)

Responsibilities:

• Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and collection of data.
• Adherence to all GMP requirements, a proficiency in understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations and inspections/audits.
• Manage sample tracking and the inventory system to track commercial and development samples.
• Generate sample submission forms for various testing facilities and process returned results.
• Collect sample forecasts to ensure lead time notice.
• Confirm testing was complete when sample invoices arrive.
• Follow/track international shipments, and alert logistics group of any customs clearance issues.
• Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs.
• Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments.
• Execute protocols to support network stability, qualified material programs and pipeline product studies.
• Create and continuously improve sample management procedures and processes.
• Communicate with other departments and sites including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
• Write and revise documents such as SOPs and technical reports.
• May support the Manager for activities related to training of employees, coordination of tasks, compliance with GMP, and identifying and implementing corrective and preventive actions.
• Support Stability sets and pulls including aliquoting and shipping during the study.
• Other related job duties as assigned.

Requirements:

• High School degree with 6 years related experience in a GMP Quality Control Laboratory or Associate’s degree with 4 years related experience in a GMP Quality Control Laboratory or Preferred, Bachelors’ degree in a relevant scientific concentration plus 2 years related experience in a GMP Quality Control Laboratory.
• Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory.
• Excellent oral and written communication skills with strong technical writing experience required.
• Able to work independently and effectively within the group, within Quality, and across the site.
• Ability to work in both paper based and electronic laboratory information management systems.