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Synectics Inc. · 13 hours ago

Quality Control Microbiology Analyst

Durham, NC

Contract

Onsite

New Grad, Entry Level

Synectics Inc. is a company focused on quality processes and standards in manufacturing. They are seeking a Quality Control Microbiology Analyst who will assist with compliance, perform microbiological testing, and document laboratory results while adhering to cGMP standards.

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Responsibilities

Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production

Performs Environmental Monitoring and Microbiological testing in support of manufacturing at the assigned GMP Manufacturing facility

Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays

Conducts routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes

Document laboratory test results in GLIMS, worksheets, forms, and logbooks utilizing Good Documentation Practices in a timely manner

Assists in drafting and revising SOPs and reports

Manages the use and maintenance of scientific equipment and instrumentation, computer systems

Responsible for limited range of laboratory support functions and procedures as assigned, developing capability in basic technical skills, disciplines, and procedures within assigned discipline area(s)

May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing operating procedures

Capable of delivering to assigned work schedule with attention to detail and accuracy

Adheres to proper cGMP's including good housekeeping, proper protection of product quality and integrity, and personal hygiene

Notifies management and initiates events (such as Laboratory Investigations) in the quality systems, with guidance from senior analysts or management

Assist in special projects on analytical and instrument problem solving by execution of assay

Gain familiarity with basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment

Qualification

Microbiological testingEnvironmental monitoringCGMP complianceLaboratory support functionsDocumentation PracticesProfessional conductTeamworkCommunication skills

Required

Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field

Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds

Learns to use professional concepts, Builds Relationships & Demonstrates Teamwork

Adheres to expected levels of conduct, including attendance and appropriate, professional behavior

Applies company policies and procedures to resolve routine issues

Ability to communicate and work in a team environment

Normally receives detailed instructions on all work

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.