QC Associate Scientist

Description:

• Under general direction, perform testing and other activities in functions supporting the Quality Control department (Micro/EM, QC Bio-assay and raw materials, as appropriate).

• Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability.

• Perform micro/EM testing such as environmental monitoring, gram stain, sterility testing, endotoxin, and mycoplasma.

• Maintain controls and reference standards to support testing.

• Follows quality policies.

• Plan and schedule assigned activities.

• Generate trend reports.

• Review/approve data generated by other team members.

• Perform method qualification/optimization of methods as per appropriate protocols.

• Contribute to OOS/OOE investigations and deviation investigations.

• Support 5S and Lean projects.

• Identify potential improvements in project work.

• Interface with regulatory agencies during audits.

• Contribute to assigned projects.

• Knowledge of LabWare LIMS and/or other QC data systems.

• Maintain GMP/GLP quality systems.

• In addition to these primary duties, provide coverage for all appropriate areas and testing.

• Performs other job duties as assigned.

• Deliver quality products and services on time to all customers, internal and external.

Qualifications:

• BA or MS in chemistry, biochemistry, microbiology or other related science.

• Fluent in English.

• 2 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.

• Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.).

• Knowledge of microbiological and environmental monitoring, bioassay, and/or raw material test methods, as appropriate.

• Knowledge of LIMS systems.

• Ability to communicate clearly with a variety of individuals in various aspects of operations.

• Detail-oriented with expertise in problem solving and solid decision-making abilities.

• Strong interpersonal skills which include a professional demeanor when interacting with personnel.

• Sound, practical and appropriate regulations

• Strong written and verbal communication skills are essential.

• Internal orientation

• Thorough understanding of cGMP requirements

• Good communication and organizational skills

• Ensure customer satisfaction and react to customer requests

• Is seen as a competent team player

• Strong ability to work independently, compliantly and results driven.

• Strong analysis and decision-making skills surrounding documentation

• Pays attention to detail

• Able to proof work and identify non-standard format or wording, and errors within documents

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.

Synectics is an equal opportunity employer.