• Job Description

  Req#: 25-277327
  
  Job Description (Required): In this role, you will:
  Perform various chemical tests such as water analysis, FTIR, ID, HPLC, and other compendial assays.
  Write and perform raw material verification protocols and associated reports.
  Ensure training records are updated and correctly filed to reflect current testing capabilities.
  Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.
  Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
  Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
  Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
  Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
  Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
  
  Here Is What You Need (Minimum Requirements)
  Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
  Demonstrated technical skills in chemistry laboratory testing
  Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
  Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.
  Excellent organizational skills and strong ability to multi-task
  Strong written and verbal communication skills
  Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
  
  Bonus Points If You Have (Preferred Requirements)
  Experience with laboratory work, particularly using analytical techniques such as HPLC, pH, Polarimetry, etc.
  Proven track record in leading continuous improvement projects
  Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
  Strong problem-solving skills and attention to detail
  Ability to manage multiple priorities and meet deadlines.
  Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
  Adaptability and willingness to learn new techniques and procedure.
  
  PHYSICAL/MENTAL REQUIREMENTS
  Non-existent to minimal travel.
  Must be able to wear appropriate PPE (e.g., lab coat, safety glasses, non-porous shoes, gloves, etc.)
  Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
  Intellectual capability to perform complex mathematical problems and perform complex data analysis.
  
  Work Location Assignment: On Premise
  
  Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.
  Support environmental monitoring/water testing in the QC Raw materials laboratory.
  Test incoming raw materials per compendial methods.
  Follow Environment Health and Safety requirements for site and QC laboratories.
  Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation.
  Operate within established HR policies and basic colleague relations guidelines.
  Write Standard Operating Procedures (SOPs), technical reports, project plans, etc.
  
  Open to Fresh Grad
  
  Hard Skills:
  1. Lab Exp
  2. Degree in Life/Phys sciences
  3. Analytical
  4. Ishihara Test (color)
  
  Interview Process:
  Panel Interview Teams (Camera-on)
  
  Schedule Flex: will review with candidates during interview.
  Position Comments visible to Supplier: MU not to exceed 45%
  

• About the company

  Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.

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