About the position
The Winston-Salem, NC location supports the Tobacco Industry. The role involves assisting in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions. The candidate will assist with Quality and Regulatory Audits and interact directly with auditors. Responsibilities also include producing internal routine and non-routine data reports for clients, reviewing and auditing complex routine and non-routine laboratory data in one or more areas (including MDV) according to departmental, corporate and client SOPs, Work Instructions, and/or Forms; reading and understanding analytical procedures. The position requires maintaining continuous learning to keep abreast of regulatory or industry standards as related to Data Review requirements, identifying potential quality system improvements to maximize quality and productivity, and assisting in the training of laboratory personnel.
Responsibilities
- Assist in conducting laboratory investigations, exceptions, planned deviations, and/or corrective and preventative actions.
- Assist with Quality and Regulatory Audits and interact directly with auditors.
- Produce internal routine and non-routine data reports for clients.
- Review and audit complex routine and non-routine laboratory data in one or more areas (including MDV) according to departmental, corporate and client SOPs, Work Instructions, and/or Forms.
- Read and understand analytical procedures.
- Maintain continuous learning to keep abreast of regulatory or industry standards as related to Data Review requirements.
- Identify potential quality system improvements to maximize quality and productivity.
- Assist in training of laboratory personnel.
Requirements
- Bachelor's degree in Chemistry, Biology, or other scientific related degree concentration.
- 4 - 7 years of related data review experience.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Nice-to-haves
- Experience in cGMP and/or ISO 17025 environment.
- Familiarity with various computer software (CDS, LIMS, EMPOWER, OpenLab, Teamo, etc).
Benefits
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
- Yearly goal-based bonus & eligibility for merit-based increases.
