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.
location: Greenville, North Carolina
job type: Permanent
salary: $55,000 - 60,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
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
- 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
qualifications:
- 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
skills: Analytical Chemistry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
