USA - Quality Control Analyst

Mindlance

Social Circle, GA

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JOB DETAILS

SKILLS

Analysis Skills, Biotech and Pharmaceutical, Change Control, Clinical Laboratory, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, Fitness, Government Regulations, Instrumentation, Interpersonal Skills, Laboratory Analysis, Laboratory Operations, Laboratory Testing, Leadership, Maintain Compliance, Manufacturing, Materials Analysis, Medical Equipment, Multitasking, Onboarding, Operational Support, People Management, Problem Solving Skills, Process Analysis, Process Improvement, Project/Program Management, Quality Control, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Standard Operating Procedures (SOP), Statistics, Technical Leadership, Technical Support, Technical Writing, Testing, Time Management, Trend Analysis, Writing Skills

LOCATION

Social Circle, GA

POSTED

30+ days ago

Actual Job Title - Senior Quality Control Specialist
Onsite - 100%

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

Responsibilities (not limited to):

Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.

Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.

Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.

Lead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.

Oversee change control management processes, including risk assessment, documentation, and implementation.

Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.

Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.

Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.

Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.

Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.

Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.

All other duties as assigned by Leadership
Microbiology experienced is NOT needed for this role.

Education and Experience Requirements:

Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.

Key Skills, Abilities, and Competencies

Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
Must have the ability of managing complex projects and resolving complex lab issues.
Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
Strong understanding of business and/or industry.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

About the Company

Mindlance

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