Associate
Associate-QualityControl
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate - Quality Control at Associate. Skills: Analytical testing, Method validation, Method verification, Quality Control, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP). Perform method transfers/ validations / method verifications to the complex analytical techniques. Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.”
What You'll Achieve.
Ensure the delivery of safe and effective products to patients.; Uphold a quality culture that adapts and evolves to meet the needs of patients.; Ensure that every product we deliver is of the highest standard.; Meet targets.
Industry & Context.
Problem-solving skills; Recommend appropriate corrective actions
What They're Looking For.
Must Have
Bachelor's Degree in Chemistry/ Microbiology with Minimum 4-5 years in Analytical testing / Master's Degree in Chemistry/ Microbiology with Minimum 2-3 years in Analytical testing, Qualified in multiple analytical techniques (HPLC, GC, UV‑Vis, FTIR, Karl Fischer, and pH meters), Demonstrated technical skills in method validation and testing, Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations, Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams., Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI)., Execute and document analytical method verification and method transfer activities., Knowledge of Good Manufacturing Practices and its application standards, processes, and policies., Excellent organizational skills and ability to multi-task, written and verbal communication skills, Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
Nice to Have
Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography), GC techniques, Proven track record in leading continuous improvement projects, knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis, 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 procedures
What You'll Do.
Perform method transfers/ validations / method verifications to the complex analytical techniques
Interpret and evaluate data for accuracy
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
and related documents to keep them current.
Conduct analyses on finished products
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.
How You'll Work.
Team & Collaboration
Coordination with cross‑functional teams.; Develop plans for work activities within a team.; Ability to communicate effectively with colleagues at all levels
Communication Scope
written and verbal communication skills; Ability to communicate effectively with colleagues at all levels
Process & Methodology
Contribute to the completion of complex projects, Manage time effectively to meet targets, Develop plans for work activities, Proven track record in leading continuous improvement projects, Ability to manage multiple priorities and meet deadlines.
Full Job Description
**Use Your Power for Purpose** Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. **What You Will Achieve** In this role, you will: * Perform method transfers/ validations / method verifications to the complex analytical techniques * 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)** * Bachelor's Degree in Chemistry/ Microbiology with Minimum 4-5 years in Analytical testing / Master's Degree in Chemistry/ Microbiology with Minimum 2-3 years in Analytical testing * Qualified in multiple analytical techniques**(** HPLC, GC, UV‑Vis, FTIR, Karl Fischer, and pH meters) * Demonstrated technical skills in method validation and testing * Ability to read and understand applicable compendial methods, Standard Operating
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