Hybrid Senior Research Associate - QC bei AVEVA DRUG DELIVERY SYSTEMS INC

Description

This position is responsible for one or more of the following activities in the Quality Control Department: Testing of in-process samples, final products, raw materials, components, microbial, and stability program (testing and reporting) samples. Administer all computerized quality systems in the lab including chromatographic data systems. Supports process validation activities. Supervises method transfers and supports method validation for analytical development. Maintains systems for cGMP compliance.

Job Responsibilities:

 •    Allocates testing schedules to ensure timely release of analytical results to meet production and stability schedules.
•    Approves data packages and release of analytical results.
•    Maintains thorough understanding of all Quality Control STPs, SOPs and data acquisition systems.
•    Initiates, reviews, and refines Quality Control STPs, specifications, and SOPs.
•    Creates and reviews protocols/reports, including instrument calibrations, IQ/OQ/PQ.

•    Authors, reviews and supports laboratory investigations.
•    Coordinates and executes method validations and method transfer from/to Quality Control.
•    Maintains technical expertise in analytical laboratory instrumentation.

•     Works as a member of a team to achieve all outcomes; 
•    Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.

•   All other duties as assigned.

Qualifications

Job Requirements:

• Education
• Degree needed 

• Knowledge, Skills and Abilities
• Hands-on experience on HPLCs, GCs, Balances, Spectrophotometers, FTIR, Chambers, Incubators and Physical Testing Instruments (for pH, pouch integrity, etc). Strong knowledge of chromatographic data management systems (i.e., Empower). Knowledge of the Stability Programs and current regulations. Experience with TrackWise and LIMS systems.
• FDA, cGMPs, and SOPs related to job requirements.
• Mathematical Skills:
      Ability to comprehend and apply principles of basic mathematics and statistical theory.  Ability to work with concepts such as limits, ranges, and numerical specifications.
• Reasoning Ability:
      Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Strong troubleshooting and analytical skills. Ability to conduct unbiased, scientifically sound laboratory investigations in a timely manner.
  Language Skills:
      Ability to read, analyze, and interpret common scientific and technical journals, Pharmacopoeias, specifications, standard operating procedures, and standard testing procedures. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write reports, business correspondence, and procedures that conform to prescribed style and format.  Ability to effectively present information to upper management and other groups.

• Experience

• B.S. degree + 7-10 years of progressively related experience and a minimum of 3 years as a Senior QC-Analyst.
• M.S. degree + 5-7 years of progressively related experience and a minimum of 2 years as a Senior QC-Analyst.