Seeking a Senior Analyst, Quality Control (QC) Raw Materials, who will be responsible for the sampling, release testing, data review, and vendor qualification, for all raw material lots received for use in the manufacturing of product. These activities include chemical and biological raw materials, component inspection, and final packaging.
A good understanding of QC test methods and raw materials release requirements per USP and EP compendia, is desired. Experience working in a GMP-regulated environment is essential. The position will report to the Raw Materials - QC Manager, 3rd Floor Laboratory.
Essential Functions and Responsibilities:
Support the planning and establishment of the initial setup of internal raw material testing laboratory.
Perform day-to-day activities for raw material release testing, including but not limited to USP<71> Sterility, USP <61> Growth Promotion, USP <63> / EP 2.6.7 Mycoplasma, USP<85> Bacterial Endotoxins, USP<197> Spectrophotometric Identification, USP <791> pH, USP <785> Osmolality, USP <841> Specific Gravity / Density, Identification by USP<191>, USP <788> / USP <787> Particulate Matter, Identification by ELISA/Immunoassay, Polyacrylamide Gel Electrophoresis, USP<643> Total Organic Carbon, and USP<645>Conductivity.
Support Acceptable Quality Level (AQL) sampling and inspection, Carbon Dioxide (CO2) sampling and testing, and other raw material releases.
Support all quality events and tasks associated to raw material release.
Author, review, and/or execute SOPs, protocols, reports, specifications, and other quality control documents as applicable.
Support raw materials vendor qualification program.
Support efforts in on-going readiness for regulatory inspections and compliance audits.
Participate in investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
Support problem solving for technical issues, pertaining to raw material testing and release.
Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
All duties are performed with supervision and oversight.
Provide supervision and oversight to entry-level analysts.
Other duties, as assigned.
Required Education, Skills, and Knowledge:
Bachelor's degree in a relevant discipline (biological sciences or equivalent).
Minimum five (5) years in a GxP regulated setting (pharmaceutical or biotechnology industry)
Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
Strong microbiological, analytical and technical background in compendial testing and related equipment.
Experience in raw material inspection and testing practices.
Experience leading and facilitating quality events including OOS investigations.
Strong analytical and technical background in compendial testing and related equipment, including microbiology, potency, gel electrophoresis, wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC methodologies.
Experience with inspections/audits by FDA and other regulatory agencies.
Experience in method validation and assay transfer.
Experience with lab and data management systems (LIMS, Empower, Phenix).
Experience managing a team a plus.
Broad knowledge of biological drug development with respect to Quality Control.
Demonstrated ability to manage external partners with respect to quality control activities.
Successfully interface with multi-disciplined teams in a global setting.
Extremely detail-oriented with strong analytical, written, and verbal communication skills.
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Demonstrate sense of urgency; ability to recognize time sensitivity.
Flexible and adaptable style with an eagerness to take on challenges.
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
Problem solver who not only identifies issues but leads efforts to resolve them.
Preferred Education, Skills, and Knowledge:
Experience with cell and/or gene therapy products is a plus.
Experience with change controls, risk assessments, and validations is highly desirable.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
Must be able to wear appropriate Personal Protective Equipment (PPE), i.e. safety glasses, shoes, vest.
Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
Must be able to use near vision to view samples at close range
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 25 pounds.
Mental:
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment:
This position will work in both an office and a manufacturing lab setting.
When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
Able to work in cleanroom with biohazards, human blood components, and chemicals.
Potential exposure to noise and equipment hazards and strong odors.