Position Title:

Senior Quality Control Specialist\n

Work Location:

Social Circle, GA 30025\n

Assignment Duration:

Months Position Summary:

The role of the Senior Quality Control Specialist is to provide technical expertise and support for the Operational Support functions of the QC Laboratory.

Key Responsibilities:

\nPerform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.\nAuthor and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.\nDesign and coordinate analytical method onboarding activities, including execution planning, training, and documentation.\nLead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.\nOversee change control management processes, including risk assessment, documentation, and implementation.\nManage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.\nAct as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.\nCollaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.\nIdentify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.\nConduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.\nCollaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.\nAll other duties as assigned by

Leadership Qualification & Experience:

\nRequires bachelor's degree in science, engineering or other related technical field.\n4+ years of related experience in pharmaceutical or similar regulated industry.\nStrong QC Microbiology experience preferred (testing, sampling, processes)\nMust know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.\nMust have the ability to manage multiple tasks and responsibilities for the QC Lab.\nMust have the ability of managing complex projects and resolving complex lab issues.\nMust possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.\nShould have advanced knowledge in Statistical Analysis and cGMP standards.\nStrong leadership, project and people management skills, and ability to make critical decisions.\nStrong understanding of business and/or industry. Applicant Notices & Disclaimers\nFor information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. 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