Senior Quality Control Analyst

The Fountain Group LLC

Social Circle, GA

JOB DETAILS
SALARY
$45–$86 Per Hour
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, Microbiology, Multitasking, Onboarding, 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
Details for the position are as follows:
  • 6-month contract to start
  • Rate: $45-86 an hour depending on experience level
  • Location: Social Circle, GA -100% onsite
Job Description:
  • 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.
Required Skills:
  • Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.
  • Strong QC Microbiology experience preferred (testing, sampling, processes)
  • 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.
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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/