QC Sr. Specialist

Description

• The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.
• Act a coordinator for Quality activities including site to site method transfer and internal project coordination.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities.
• Performs trend analysis of methods /environmental data / assay controls and standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Support department risk assessments and participates in audit walk-throughs.
• Participates in the preparation of investigations, summaries and reports.
• Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
• Oversees special projects on analytical and instrument problem solving.
• May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate technique and related topics.
• Other related job duties as assigned.
  
  

Qualifications

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 8 years' experience in GMP environment or 7 years' at GTx.
• Familiarity with cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV), AUC, compendial assays (Bioburden, pH), electrophoresis (CE, Western Blot), cell culturing, and Microbiology/Release sampling (EM, Compressed Gas).
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
• Proven ability to work effectively in a team environment.
• Collaborates cross functionally with other departments to achieve site goals.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. 
• Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
  
  

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.