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Quality Control Analyst II - Microbiology

Sunrise Systems Inc

Fort Worth, TX

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JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Communication Skills, Corrective Action, Documentation, English Language, Follow Through, Identify Issues, Laboratory, Laboratory Operations, Maintain Compliance, Microbiology, Multitasking, Problem Solving Skills, Quality Control, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Schedule Development, Secondary School, Standard Operating Procedures (SOP), Time Management, Warehousing
LOCATION
Fort Worth, TX
POSTED
4 days ago
Job title: Quality Control Analyst II - Microbiology
Location: Fort Worth, TX (Onsite)
Duration: 12 months
Interviews: 2

Job Description:

The Quality Control Analyst II is responsible for maintaining high standards of laboratory operations and ensuring compliance with regulatory requirements. Key responsibilities include:
  • Performs microbiological validations for raw materials and finished products, including Bioburden, Endotoxin, Sterility, and PET.
  • Provides support to QC Microbiology laboratories.
  • Conducts equipment qualifications.
  • Organizes and assists with Media Fill and Reads.
  • Identifies ongoing quality issues, prevents potential problems, and suggests improvements.
  • Interprets and evaluates analyses for accuracy and precision against established specifications, recommending and implementing corrective actions when necessary.
  • May be responsible for analytical and protocol report writing, as well as standard operating procedures.
  • Strictly adheres to Good Documentation Practices (GDP).
  • Collaborates with and supports coworkers to enhance the organization's overall capabilities.
  • Communicates effectively with production, maintenance, warehouse, and other relevant functions.
  • Participates in problem-solving and troubleshooting.
  • Supports training needs of team members and works cohesively with the team.
  • Coordinates with and supports other departments to ensure smooth workflow execution.
  • Ensures the availability of supplies and equipment to meet schedules and carries out tasks as defined by the schedule.

Qualifications:
  • Bachelor's Degree or equivalent years of related experience (or high school + 8 yrs; Assoc. + 4 yrs)
  • The ability to fluently read, write, understand and communicate English

Desired Competencies:
  • Strong knowledge of pharmaceutical regulatory requirements
  • Excellent Communication skills, in both verbal and written form
  • Highly attentive to details and comfortable speaking up
  • Self-Starter with the ability to follow up on and complete multiple projects simultaneously with little direction
  • Able to work overtime and flexible work hours to meet department goals

Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com

About the Company

S

Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/

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