Lead QC Associate III, Raw Materials
Research Triangle Park, North Carolina
The QC Lead Associate Ill position is a shift lead function, assisting laboratory management with the coordination and assignment of activities within the Quality Control Laboratory. The incumbent attends Tier Board meetings, relays status of QC testing to the manufacturing and quality groups, and identifies manufacturing activities which require scheduled testing support. The individual relays this information to the QC Tier Boards, informs and consults with lab management, and coordinates or assigns activities within their assigned area of responsibility. The position will also support routine testing by testing samples, reviewing data, and delivering RFT, on-time results to the various QC customers.
The individual has demonstrated analytical capability and is able to apply knowledge and experience to the tasks of lab coordination and work scheduling. The individual coordinates the scheduling, task assignment, and data delivery to the customer according to current manufacturing and testing calendars. The position coordinates with analysts and area management to assure campaign and equipment readiness. The individual may review SOPs, protocols, summary reports or forms to assure accuracy and suitability for routine or ad hoc laboratory testing. On occasion, the individual may prepare protocols and procedures to facilitate project or technical transfer activities.
Other responsibilities include, but are not limited to:
- Informs/consults with management regarding resource conflicts.
- Works with department leadership to assure priorities and activities such as housekeeping, lab supply inventory, etc. are maintained according to schedule. Evaluates new raw materials for test and sample requirements with compliance to company policies and procedures, compendia (USP, EP, JP, ACS) and ICH requirements
- Provides Quality Control SME assessment for deviations, laboratory OOS investigations, Change Controls and Supplier Change Notifications related to Raw Materials method and analytical instrumentation for testing not directly performed.
- Tracks and coordinates timeliness of laboratory investigations, deviations and corrective actions
- Participates on project teams and collaborates throughout the project lifecycle ensuring analytical data compliance.
- Revises and reviews master plans, SOPs, work instructions and training course plans for analytical instrument operation, raw material test methods, ensuring alignment with qualification documentation.
- Serves as SME during audits for raw material issues, as needed.
- Supports all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution, and data review.
- Applies lean lab and six sigma principles to daily activity
- Reviews analytical data associated with raw material testing, including results from third party contract laboratories and method qualification / validation protocols, ensuring compliance to specifications I acceptance criteria, for testing not directly performed
- Serves as a contact for contract laboratories, QC and Analytical PD for raw material issues.
- May generate reports and recommendations; can identify statistically significant and impactful events
- May lead and/or coordinate method transfers, qualifications, and validations
- May act as a coach to new or junior analysts
- Coordinates or assists in resolving laboratory or sample-related issues
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Lab Coordination activities- 65%
Laboratory analysis- 25%
Other activities- 10%
This position reports directly to the laboratory manager or supervisor. There are no assigned direct reports.
The position is a part of the regular analytical staff, reporting to the laboratory manager or supervisor. There are no direct reports or budget responsibilities.
Minimum Education Requirements
- BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field
- 6+ years related laboratory experience (4 years required with relevant MS degree)
Specific Skills and Competencies
- Strong Trackwise background preferred
- Highly collaborative
- Team oriented
- Capable of high through-put and high quality, RFT work
- Certified or capable of timely certification for Yellow Belt
- Demonstrated subject matter expert in several analytical disciplines Proficient technical writing skills
- Able to make informed and timely decisions independently
- Can manage multiple assignments in timely and effective manner
- Effective communication skills with colleagues both within and outside of the department
- Capable of recognizing process gaps and implementing improvements
- Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.