Quality Control Sample Coordinator

Merck & Co.; Durham (NC); On-site; USD 30,307,000 - 46,838,000; Full time

Job summary

Merck & Co. is seeking a Quality Control Sample Coordinator onsite in Durham, NC. The role covers oversight of QC samples, data management, and adherence to GMP, with emphasis on collaboration with Quality, Manufacturing and Facilities to address compliance and process improvements.

The ideal candidate will have GMP QC lab experience, strong written and verbal communication skills, and the ability to work independently within a team. This is a 7-month, onsite position with standard daytime hours.

Qualifications

• Bachelor's or Associate's degree with GMP QC lab experience or high school with relevant GMP experience
• Excellent written and oral communication with strong technical writing
• Ability to work independently and cross-functionally within Quality and site

Responsibilities

• Oversee in-process, release, raw material and stability samples and related data management
• Ensure compliance with GMP; interact with Quality management; support investigations and inspections
• Manage sample tracking and inventory for commercial and development samples
• Generate submission forms for testing facilities and process results
• Coordinate sample forecasts and ensure timely testing and invoicing
• Monitor temperature data from shipments and review SOPs for sample handling
• Create and improve sample management procedures and participate in corrective actions

Job description

Job Title: Quality Control Sample Coordinator

Location: Onsite, Durham, NC

Shift: Monday - Friday (7 AM - 4 PM or 8 AM - 5 PM)

Duration: 7 months

Pay Rate: ***/hr - ***/hr

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.