Microbiology Quality Control Analyst

SRG4 offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG4 utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Microbiology Quality Control Analyst

Location: Sunrise, FL

Industry: Pharmaceutical

Hours: Monday-Friday, 8am-5pm

Salary: Up to $33.50/hr.

Employment Type: Contract, on-site 100%

Environment:

Our client is a global leader in generics and biopharmaceuticals, improving the lives of patients across the world. Today, our portfolio of around 3,500 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of our quality medicines every day. We invest in research and development of generic medicines and biopharmaceuticals, carrying on the legacy of more than a century of finding new ways to help patients improve their lives.

Summary:

• This position performs testing of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records.Experience with Labware LIMS V7 and laboratory auditing processes
• Microbiology testing experience on Environmental Samples for surface and air, Purified Water Samples, and RM/FP Microbial Limit Test following USP, Gram Staining
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS)
• Ability to communicate effectively with excellent written and oral communication skills for scientific and/or technical ideas
• Acts independently and proactively to recommend methods and procedures for problem resolution
• Self-directed with ability to organize and prioritize work
• Understand Data Integrity (ALCOA+) and laboratory documentation practices
• Responsibilities: Complies with all safety rules and regulations.
• Perform analysis on raw materials, finish goods, API, and control substances
• Ensures that balances are reviewed and calibrated.
• Perform peer review of laboratory testing as required.
• Responsible for Wet Chemistry testing (such as LOD, PH, titration, etc.)
• Work within a team to meet productions, validation, stability, and request deadlines.
• Participates in troubleshooting of analytical test methods and laboratory instruments.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP s), and Standard Operating Procedures (SOP s) instructions.
• Responsible for performing additional related duties as assigned.
• Requirements:Bachelor s degree, preferably in Chemistry, Microbiology, Biology or equivalent education/experience
• Minimum of two years relevant progressive experience in a Quality Control in cGMP pharmaceutical, biotechnology or environmental laboratory with an emphasis on Microbiology
• Microbiology testing experience on Environmental Samples for surface and air, Purified Water Samples, and RM/FP Microbial Limit Test following USP, Gram Staining
• Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Labware LIMS and/or Empower preferred experience preferred.
• Skills/Knowledge/Abilities:Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.
• Ability to effectively communicate scientific and/or technical ideas in writing.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with the ability to identify errors and/or inconsistencies while performing tasks.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
• Must be able to maintain the highest levels of confidentiality, integrity and discretion.
• Excellent verbal, written, and interpersonal skills required.
• May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process

EOE/ADA