Job Search Results for biotech

One of Insight Global's biotech clients is seeking a detail-oriented and proactive Quality Engineer - CAPA to lead quality initiatives across the product lifecycle. This role is ideal for someone... More with a strong foundation in quality systems, risk management, and continuous improvement, particularly in regulated environments.Key Responsibilities:- Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision. - Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards. - Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements. - Ensures success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, driving continuous enhancement of product quality and reliability. - Conducts thorough assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and address quality deficiencies, ensuring the highest standards of design excellence. - Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements. - Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality. - Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary. - Ensures preparation for quality audits and inspections, maintaining all necessary documentation and processes to demonstrate compliance with both internal and external quality standards. - Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of solutions to prevent recurrence and drive continuous improvement. - Applies continuous improvement techniques to enhance quality practices, ensuring ongoing audit readiness and strict adherence to both internal and external quality standards throughout the product lifecycle. - Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestonesCompensation:$40-48/hourExact compensation may vary based on several factors, including location, skills, experience, and education.Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is hiring two EHS Lockout/Tagout (LOTO) Planners to support a high-profile biopharmaceutical expansion project in Holly Springs. These roles will be essential in maintaining... More GMP-compliant safety protocols and developing lockout/tagout plans that meet OSHA, NFPA, and site-specific standards. If you thrive in a planning-heavy, fast-paced commissioning environment and have a strong EHS foundation, this is the perfect opportunity to join a high-impact safety team.Responsibilities: Build, document, and manage LOTO plans using SOPs, equipment manuals, and P&IDsEnsure contractor and internal procedures meet GMP, OSHA 1910.147, and NFPA 70E standardsDraft and oversee the completion of: ? LOTO Permits ? SSOW (Safe Systems of Work) ? JHA (Job Hazard Analysis) ? LOTO Documentation PacketsSupport field lock and tag activities; verify isolation and zero-energy conditionsAct as a technical resource for contractors and internal teams during commissioning activitiesMaintain clear and accurate documentation aligned with ALCOA principlesSchedule: Wed?Sat, 12pm?10pm (4x10s)? Alternate schedule potential: Tue?Sat, 2pm?10pm (5x8s)We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

One of our large pharmaceutical clients is looking to hire an Associate Scientist of Cell Banking to perform Cell Banking for the Cell Culture processes and/or bio-analytical testing within the API... More Large Molecule Process Development group in Malvern PA. The candidate's primary responsibilities will include but are not limited to the production, testing, inventory, and supply of Master, Working, and development Cell Banks for clinical, and commercial production as well as analytical testing for biopharmaceutical and cell therapy products. Responsibilities will include: -Support Cell banking organization by performing Cell banking for Cell Culture processes and analytical testing. -Execute production, testing, and release of Master, Working, development, and analytical cell Banks and ensures the timely supply to customers. -Work in a team environment as well as contributing individually to meet project timeline and objectives. -Participate in Cell culture and cryopreservation of cells using aseptic techniques under GMP Compliant conditions. -Execute all activities per established procedures and protocols -Interface with internal and external customers to ship cell banks and supply critical information as per their requirements. -Collaborate cross-functionally to represent Cell Banking department. -Author, review, and approve technical documents, SOPs, and batch records.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

Insight Global is looking for an experienced Medical Sales Consultant to join a Fortune 500 pharmaceutical companing selling oncology products and pharmaceuticals across a field territory in Orange... More County, CA. The Oncology Sales Consultant targets, will sell and promote oncology products to oncologists and other specialized oncology medical or healthcare providers. The Oncology Sales Consultant will also manage their territory to maintain existing accounts, develop acquisition plans for new accounts and to achieve district and corporate objectives. As a member of the oncology squad, the sales consultant will work closely with their Area General Manager and other squad team members to achieve overall objectives. This person will provide quality consultative information, coordinate and integrate outside alliances/internal personnel to fit customer needs.Day-to-day responsibilities are as follows:- Demonstrate a mastery of products clinical efficacy- Articulate a strong value proposition for the customer and provide patient and reimbursement support- Meet/exceed sales targets- Target, develop, assess, and maintain key customers- Use strategic thought process in developing and maintaining an active customer database- Utilize mastery of clinical and technical knowledge related to products promoted and disease state management- Key account management, best practices, and sales development- Develops business plans with resource allocations that link to strong business results- Demonstrate a mastery of knowledge and analysis of business, products, technical issues, and the marketplace- Adhere to company compliance guidelines, policy, and proceduresWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Leads projects and participates on cross-functional teams to address business systems needs/issues. Plans and develops the analysis of complex business problems to be solved with automated systems.... More Provides technical assistance in identifying and evaluating systems and procedures that are cost[1]effective and meet user requirements. Plans and executes unit integration and acceptance testing; and may create specifications for systems to meet business requirements. Provides consultation to users in the area of automated systems.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less

A Life Science company based in San Diego, CA is seeking a Principal Technical Project Manager to join their team. Leads cross-functional teams to address business systems needs/issues. Plans and... More directs the analysis of complex business problems to be solved with automated systems. Provides technical leadership in identifying, recommending and evaluating systems and procedures that are cost-effective and meet user requirements. Plans and leads unit integration and acceptance testing; and may create specifications for systems to meet business requirements. Provides consultation to users in the area of automated systems.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.Less