The QC manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 GMP operations to ensure compliance with regulatory requirements and managing the quality control functional group. The QC manager will interact with customers to respond to their question/concerns/needs of analytical services including but not limited to stability studies, method development and/or transfer. The Quality Control team is responsible for all analytical activities associated with the support of manufacturing activities, including raw material testing. The QC manager is responsible to foresee the QC workload; trend and plan adequately in response to the increasing demand for QC services.
The QC manager is responsible for setting and overseeing the objectives of the quality control group, serving as technical lead for method development, providing appropriate oversight to ISO 9001 and ICH Q7 GMP operations to ensure compliance with regulatory requirements and managing the quality control functional group
- Maintain, supervise and participate in the daily activities of the QC laboratory by establishing testing priorities and scheduling of staff in coordination with company goals/priorities
- Perform and assist with laboratory investigations and other quality events
- Provide daily guidance, mentoring, and feedback to staff
- Oversee and participate in product testing to identify any deviations/out of specifications
- Ensure QC equipment calibrations and maintenance are completed as scheduled
- Review laboratory notebooks, raw data, reports, protocols, etc., as necessary
- Author/review QC analytical SOPs, protocols, etc
- Perform change controls to update current analytical GMP documents
- Ensure QC laboratory compliance and audit-readiness with applicable regulations
- Author/review method validation protocols/reports
- Oversee/perform method development/validation/ verification activities for API and drug products
- Supervise procedural, cGMP, and safety training of laboratory staff
- In coordination with QA, ensure QC activities adhere to cGMP regulations and any other regulatory guidelines
- Assist with preparations for internal and external laboratory audits and inspections
- Ensure the Safety Guidelines set forth by the company are followed in the QC lab
- Other related duties as required
Successful applicant will demonstrate:
- Superior reasoning and problem-solving skills with the ability to exercise sound judgment and make decisions based on accurate and timely analyses.
- Excellent interpersonal, communication and writing skills.
- Ability to effectively present information and respond to questions from management, peers, and external personnel. Attention to detail in communication with management as well as staff is essential.
- Aptitude at identifying prospective problem areas and recommending process improvements.
- Ability to manage multiple tasks, meet deadlines, and work under pressure in a fast-paced environment with attention to detail.
- High level of integrity and dependability with a strong sense of urgency and results-orientation.
- Fundamental understanding of the drug development process, scientific methods and thought.
- Thorough knowledge of FDA requirements pertaining to the quality control in CFRs for pharmaceutical manufacturing. Experience in device quality control is additionally preferred.
- Ability to carefully proofread reports and determine appropriate action.
- Computer skills necessary to maintain integrated quality system. Extensive word processing and data entry work on computers will be involved.
- Bachelor’s degree and > 5 years industry experience or PhD with > 2 years industry experience in Chemistry, polymer chemistry/physics or related discipline
- 5 years’ experience (2 years in a supervisory role) in a QC or analytical chemistry laboratory
- Understanding of FDA regulations (21 CFR 58, 210, 211, etc.) and USP
- In depth knowledge of analytical testing of raw materials, in-process samples, finished products and analytical laboratory instrumentation, such as HPLC, GC, FTIR, TOC, NMR, dissolution apparatus, etc. SEC-MALS experience is preferred.
- Strong investigational skills to determine root cause and identify effective corrective actions
- Strong communication and listening skills, with excellent observational, analytical, and problem-solving skills
- Knowledgeable with regulatory compliance and skilled in understanding/ interpreting scientific and technical data
- Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision
- Experience with analytical methods development and validation
- Experience with equipment calibrations, maintenance and qualifications
- Proven ability to lead, coach, and motivate employees
Diversity is important at Synedgen. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
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