Quality Control Analyst

Description

• As a QC Analyst II, you will support various activities within the QC department.
• Execute analytical method transfers, including raw materials, for use in a cGMP environment in Quality control.
• Cnducting biological or chemical and physical analyses on raw materials, in-process samples, drug substance and final product samples and other samples collected from manufacturing areas.
• Conduct biological, chemical, and physical analyses on samples including raw materials, initial, in-process and final products, and samples collected from environmental monitoring according to SOP and pre-approved protocols.
• Drive implementation of new methodologies, or new sample types into existing methods in a QC laboratory
• Support Investigation of non-conformances and troubleshoot unexpected results.
• Handle multiple tasks concurrently including testing and inventory management in a timely and appropriate manner.
• Perform review of test data, which includes overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems.
• Support generation and documentation of validation protocol deliverables.
• Draft and update, as required, QC SOPs.
• Perform test equipment, equipment maintenance and calibrations as required.
• May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations.
• Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
• May work around Methotrexate, which is a known cell growth inhibitor.
• May require immunization before performing work within the manufacturing area.
  
  

Qualifications

• High School degree or equivalent required
• Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred
• Minimum 2 years of related work experience
• Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
• General understanding & knowledge of the following areas:
• Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.
• Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Wet and instrumental methods of analyses.
• Operating and troubleshooting procedures for lab equipment
• General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred.
• Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.
• Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis is a plus.
• Solid team player, able to meet deadlines and changing priorities.
• Able to communicate effectively with managers, peers and subordinates.
• Very detailed oriented and able to produce high quality of work.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.
• Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines.
• Strong decision-making skills, technical problem-solving ability, and analytical skills.
  

Physical Demand

• The overall physical exertion of this position requires light to medium work.
• May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours
• May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours
• May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours
• May be required to lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift
• May be required to carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to 5ft
• Requires repetitive use of both right and left hands over 4 hours
• May require simple and power grasping between 3-4 hours
• May require fine manipulation up to 1 hour
• May require pushing/pulling with hands/arms between 3-4 hours
• May require office work activities with hands/arms between 3-4 hours in all Quality areas
• May be required to gown frequently and balance when gowning into clean areas
• May be exposed to noise above 85 dBA. This may require hearing protection and other protective equipment to be worn.
• May work and have exposure to hot, cold, wet environment/conditions.
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)
• May be required to work at heights above floor level
• May require the use of special visual or auditory protective equipment
• May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste in all Quality areas.
• May be required to work in confined areas.
  
  

California Fair Chance Act

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

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.