Quality Control Sample Coordinator

Description:

• 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.

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

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities