Analytical Chemist II, Quality Control

Quality Control Greenville, North Carolina


Description

Position Overview

This position is responsible for independently performing routine and non-routine analytical testing in support of pharmaceutical products following all applicable safety, quality, and regulation requirements. 

Key Responsibility Areas

  • Analytical Testing:  With limited supervision, perform a broad array of primary and advanced analytical testing methods (wet and dry chemistry) in compliance with all cGMP and regulatory guidelines and ensure the highest standards for efficiency, right first-time measures, and quality standards
  • Data Interpretation and Problem-Solving:  Use appropriate resources (e.g. software) to investigate and interpret data in support of recommendations for problem-solving related to methods, instruments and analytical techniques
  • Process Improvement:  Identify and recommend opportunities for improved efficiencies, client service and teamwork within the analytical group
  • Quality:  Ensure the integrity of data, quality of work, products and services as a first priority; complies or exceeds all regulatory and cGMP compliance standards as well as ensure accuracy of analyses as it relates to right first-time measures
  • Safety:  Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for excipients, new chemical entities and/or drug products
  • Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements
  • Interpret data and make recommendations to management for improvement or potential concerns
  • Create report templates and/or enter data into established reports/templates or software-based systems
  • Under general supervision, author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members
  • With guidance, propose applicable specifications based on data obtained in support of certain programs
  • Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
  • Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
  • Direct and assist in laboratory personnel training when required
  • Under general supervision, evaluate and validate methods of analysis for chemical entities and drug product formulations
  • Provide assistance with method development to ensure methods are robust and able to be validated
  • May serve as a technical liaison between functional groups such as Quality Assurance and metrology
  • Conduct peer review of routine and complex laboratory experiments for accuracy and provide guidance to junior team members to ensure future compliance
  • Maintain proficient knowledge in the use of Empower and other software-based systems; perform supervisory sign-off for electronic reports

Key Competencies/Requirements

  • Attention to Detail:  Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently.
  • Equipment Operation: Is skilled in the use and trouble-shooting of key equipment important in the delivery of the job. 
  • Listening:  Active listening, hearing and learning from what others say.
  • Operating Equipment:  Understands and promotes the effective and full utilization of tools, machines, and equipment in the performance of their roles.
  • Organization:  Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity.
  • Quality:  Prioritizes and delivers highest levels of quality in work and interactions with customers and team members.
  • Technical Learning:  Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
  • Training Others:  Carefully and fully articulates methods and approaches in a way that is understood by using delivery mechanisms that meet the needs of the learner. 

Qualifications

  • Associate degree in Biotechnology, Chemistry or equivalent science degree with 4 years of professional experience in pharmaceutical analytical chemistry
  • BS or BA degree in a science-related field (e.g. Biology, Chemistry, Pharmaceutical Sciences) with 3 years of professional experience in pharmaceutical analytical chemistry
  • Master’s degree in a science-related field with 2 years of professional experience in pharmaceutical analytical chemistry
  • PhD in a science-related field with at least of 1 experience in pharmaceutical analytical chemistry

Equal Employment Opportunity and Employment Eligibility 

Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Mayne Pharma is an E-Verify employer.