Principal Scientist

Certified Group partners with customers to deliver innovative scientific solutions and expertise - So The World Can Trust In What It Consumes. As a leading provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group includes Food Safety Net Services (FSNS), FSNS Certification & Audit, Certified Laboratories, EAS Consulting Group, and Labstat International Inc. Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, nicotine, cannabis, and hemp industries.

We are currently looking for a Principal Scientist t to join our growing team!

In this key role you maintain and carry out validation and process validations in timeframes as per protocol, method, standard operating procedures and/or management approval. Make detailed observations, analyze data, interpret, and report results. Schedule frequent meetings with top management to deliver presentations, protocols, reports, and all other data to keep them current on all projects and equipment schedules.

ESSENTIAL RESPONSIBILITIES:

• One year contract project working under supervision to execute validation protocols to perform and document method validations, make detailed observations, analyze data, interpret, and document results.
• Under supervision execute plans, requirements, and protocols necessary to complete validations and process validations.
• Perform and/or coordinate qualifications and validations and ensure compliance with specifications as listed in internal SOPs.
• Act with impartiality and work in accordance with the Chemistry Laboratory and management.
• Act in a way to not be influenced by particular perspectives, value judgments, community bias, or personal interests that could compromise impartiality.
• Communicate possible impartiality risks to supervisor and/or management from the Chemistry Laboratory operations.
• Ensure that all validations and process validations follow FDA and DEA regulations. USP, ICH guidelines and 21 CFR should be referenced to maintain the quality and processes as they apply to validations and process validations.
• Operate, maintain, and troubleshoot laboratory equipment and instrumentation required for tests, research, or process control to ensure all analyses can be performed as needed.
• Must be able to work independently and in a team environment to conduct qualification activities using a science and risk-based approach.
• Coordinates the review, organization, filing and scanning of all calibrations, qualifications, and all associated equipment documentation.
• Carryout and/or review software validations, and laboratory data for completeness and accuracy when necessary.
• Work primarily in a laboratory environment with the appropriate PPE for hazardous solvents and follow established laboratory safety practices.
• Work productively with all personnel in the laboratory.
• Receive a satisfactory evaluation of job performance.
• Job duties may be revised at the will of the organization.
• Adhere to established laboratory safety practices.
• Complete documentation with accuracy and per GDP.
• Maintain confidentiality of all work, methodologies, processes, and customer list.

MINIMUM QUALIFICATIONS:

• Minimum of a Baccalaureate Degree is required; concentration in Biological or Chemical Science is preferred.
• A minimum of two (2) years in the cosmetic, pharmaceutical, or related field is required.
• A general working knowledge of 21 CFR, USP/NF, ICH, cGMP, GLP and/or ISO standards and guidelines.
• The ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.
• The ability to communicate effectively and solve complex problems.
• The ability to communicate clearly in English, both orally and in writing, with scientific and non-scientific personnel is required.
• Must be proficient in using Windows programs, Access, Acrobat, Chromeleon, Qtegra, Omnic, ValPro, Data Logger Software, Sievers DataPro2, and Insight with the ability to access, input, and retrieve information using a computer.
• Lift and move heavy items in the laboratory (glassware, solvent bottles, equipment, etc.).
• Able to work efficiently under pressure and successfully function in a fast-paced environment.
• Access, input and retrieve information using a computer.

BENEFITS:

• Progressive 401k Retirement Savings Plan
• Employer Paid Short- Term and Long-Term Disability, and Life Insurance
• Group Medical
• Tuition Reimbursement
• Flexible Spending Accounts
• Dental
• Paid Holidays and Time Off
• Many positions which qualify for the company bonus program

Certified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

Monday through Friday, 8:00 AM to 5:00 PM, evenings and weekends as required.