The Principal QC Analyst is responsible for providing technical expertise to the Quality Control function to support all scale up and commercial operations. The Principal QC Analyst is the mastery level of exceptional performing Senior QC Analysts. Principal QC Analysts deliver sustained contributions that result in new and/or improved processes and methodologies. Employees at this level are recognized as masters of analytical techniques and are points of contact for troubleshooting methodologies and instrumental problems. Generally they have developed into a “go to” analyst for a particular analytical technique. Individuals in this roll are very independent and self-motivated.
This analyst will be responsible for method and process development to support raw material and finished goods testing. He/She communicates and interacts with internal and external stakeholders, including regulatory bodies. Analysts at this level have demonstrated significant scientific and technical breadth to support analytical test methods in a pharmaceutical manufacturing facility. While this role does not have direct supervisory responsibilities, it is a key member of the QC Leadership Team and is expected to provide significant time and effort to coaching and developing the organization.
- Exhibits analytical mastery across all testing methodologies in the QC laboratory pertaining to pharmaceutical manufacturing and serve as a mentor and coach for individuals within the QC organization. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (polarimetry, loss on drying, heavy metal content and viscosity, etc.).
- Executes analytical testing and transferring of methods independently with high quality while meeting or exceeding customer timelines. These methods will be executed in accordance of USP/NF/EP/JP/FCC/etc. or customer supplied guidelines
- Performs experimentation with minimal to no analyst error problem reports.
- Executes documentation with minimal to no major corrections (incorrect weights/dilutions used, improper formulas used, wrong purity, expired solutions used, etc.) and minimal minor corrections (improper cross reference, wrong date, improper correction, etc.).
- Able to seamlessly move into role of a QC Lead or QC Manager on a periodic basis in the absence of formal management staff or as part of a special project.
- Develops and leads training for QC and Senior QC Analysts on test methods and SOPs.
- Assists QC Management Team with customer and FDA audits, and follow-up with responses to observations.
- Oversees “out of specification” and aberrant lab investigations.
- Reviews and signs off on analytical data and Certificates of Analysis.
- Will play a critical role in providing day to day and year end performance feedback to analytical team. While this role will not be responsible from a formal reporting relationship perspective, it is expected that coaching, mentoring, teaching and technical development will be a core piece of responsibilities.
- Education combined with Work Experience
- Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 7 to 10 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role
- Masters Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology) with 4 to 8 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role
- PhD in Chemistry (Preferred in Analytical Chemistry or Pharmaceutical Sciences) with 0 to 3 Years in a Quality, Laboratory or Clinical role (including time as a post doc)
- Exceptional laboratory knowledge and skill set with a demonstrated ability to understand, perform, and recognize problems with compendia and costumer supplied testing methods.
- Mastery with analytical techniques as pertaining to a pharmaceutical manufacturing setting. Analytical mastery will be exhibited in chromatographic techniques (HPLC, TLC and GC, etc.), in-process/finished product analysis (blend/content uniformity, dissolution, related substances, and potency, etc.) and raw material analysis (Titration, polarimetry, loss on drying, heavy metal content and viscosity, etc.). This is achieved by recognition both inside and outside of quality assurance as a “go to” individual in all areas of testing
- In-depth understanding of cGMP regulations and FDA/USP/EP/BP/ICH guidelines.