Knack NY

We are #hiring for Senior QA Deviation Investigator, please review the Job Description below:

We are #hiring for Industrial Engineer, please review job description below:

We are hiring for Medical Writer, please find job description below:

We are Hiring for the Sr Quality Engineer I - Automation and CSV based in Frederick, MD. Please review the description below: Responsibilities: -Provide oversight for Commissioning, Qualification, and Validation (CQV) activities. -Represent site in global matrix team for strategic CQV alignment. -Serve as Site Quality Engineering SME for local CQV deliverables. -Guide QE CQV team and cross-functional system owners. -Assist in regulatory inspections, audits, and vendor qualification. -Identify root causes and implement corrective/preventative actions. -Ensure compliance with regulations and SOPs. -Author technical investigation reports. -Utilize advanced statistical techniques for data analysis. -Recommend/implement improvements to CQV processes. -Support other QE functions as needed. Basic Qualifications: -Master’s degree with 4+ years of QE experience OR -Bachelor’s degree with 6+ years of QE experience. Preferred Qualifications: -BA/BS in technical discipline with 6+ years or MS with 4+ years in GMP environment. -Working knowledge of database and software validations. -Familiarity with regulatory requirements (21 CRF Part 11/210/211, ICH Q8/Q9/Q10). -Expertise in GAMP5 and 21 CFR Part 11. -Understanding of cGMP, GAMP, and quality systems -Knowledge of ICH Q9 and Risk Management resources -ASQ certification (Six Sigma Black Belt, Quality Engineer, Quality Manager) -Experience with electronic validation software and Manufacturing Execution Systems Benefits: Professional development opportunities Dynamic and collaborative work environment H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE) Contract to PERM role OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We Won’t work on C2C for GC and USC candidates If you meet the qualifications and are interested, please apply  with your updated resume. Thank you for considering the opportunity.

We are #hiring for the below position Job Title: Quality Systems Specialist Location: South San Francisco, CA Background: Our client is looking for hands-on support to assist with different Quality, Policy, and System initiatives. Job Responsibilities: -Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations. -Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.  -Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly. -Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases. -Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required.  -Supports the maintenance and improvement of quality systems processes, as needed.  -Works directly with operating entities and internal clients to ensure follow-up of change tasks.  -Participate in compliance audits as required.  -Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). -Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. -Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks. -Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.   Required Skills:  -Pharmaceutical/Biotech Experience – 4+ years -Change Control Experience -GMP Experience -21 CFR Part 11 Experience   Desired Skills -Veeva QMS Experience Benefits: -In house training -Professional development opportunities -Dynamic and collaborative work environment -H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE) -Candidate MUST BE Authorized to work in the United States -Contract to PERM role OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We Won’t work on C2C for GC and USC. If you meet the qualifications and are interested, please DM with your resume. Thank you for considering this opportunity. We look forward to the possibility of you joining our team and contributing to our strategic objectives.

Job Title: Validation Engineer I/ II Duties -Perform Smoke studies and assist in semi annual Media fill qualifications as a SME -Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas. -Has worked with Ellabs data loggers and software -Write and execute protocols and complete final reports. -Understanding of cleaning validation concepts and principles. -Understands pharma grade utilities ( water HVAC, gases) -Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment. -Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment. -Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready" at all times. -Support Change Control, Deviation and CAPA activities Skills: - -Aseptic processing -Protocol generation -Sterilization -Validation -FDA/USDA Education:  -Bachelors , preferable in a science or engineering related field Required Skills:  -HVAC -VALIDATION ENGINEER -CGMP -FILLING LINES -BIOPHARMACEUTICAL Benefits: -In house training -Professional development opportunities -Dynamic and collaborative work environment -H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE) -Candidate MUST BE Authorized to work in the United States -Contract to PERM role OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We Won’t work on C2C for GC and USC. If you meet the qualifications and are interested, please DM with your updated resume. Thank you for considering this opportunity. We look forward to the possibility of you joining our team and contributing to our strategic objectives.

Job Title: Manufacturing Associate I Location: Fremont, CA Duties: -Execute routine unit operations in Manufacturing Assembly and Packaging, aiding in drug product manufacturing under limited supervision. -Assist Sr. Associate and Master Associate with assembly and packaging, troubleshoot equipment. -Set up automated assembly machines, gather tools, and retrieve components from storage. -Assist with equipment changeovers, minor repairs, and real-time problem resolution. -Perform all work following Company Policies and Procedures, document activities in controlled documents. -Clean production areas, transfer and dispose of rubbish, and ensure equipment calibration. -Perform assembly, packaging, visual inspection, and filling operations as needed. -Stock components, move products and components, communicate with shift change personnel, and maintain production areas per standards. -Adhere to safety standards and report unsafe conditions. Requirements and skills: -Organizational skills and teamwork. -Proficiency in basic math and detail-oriented tasks. -Strong written and verbal communication. -Experience in GMP environments preferred. -Basic computer skills (MS Office, Outlook). -Requires constant standing and walking, with some moderately disagreeable conditions. -Requires concentration, ability to discuss issues openly, and maintain even temper. -Dependent on shift, must meet attendance policies. -Maintain qualifications, adhere to SOPs and company policies, proper documentation practices, and cGMP standards. Education: High School degree with at least one year of GMP industry experience. Preferred: Associate/Bachelor degree or biotechnology vocational training. Required Skills: Biotechnology, Equipment Calibration, Documentation, Computer Operations, Sanitization Additional Skills: GMP, MS Office, Entry Level, Detail-Oriented, cGMP, Packaging, SOPs, Vocational Training, Filling Operations, Operations, Assembly, Real-Time, Networking, Safety Standards, SOP, Batch Record, CNC, Adjustments, Microsoft Office, Excellent Written and Verbal Communication Skills, Batch Records Benefits: -In house training -Professional development opportunities -Dynamic and collaborative work environment -H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE) -Candidate MUST BE Authorized to work in the United States -Contract to PERM role OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We Won’t work on C2C for GC and USC. If you meet the qualifications and are interested, please DM with your updated resume. Thank you for considering this opportunity. We look forward to the possibility of you joining our team and contributing to our strategic objectives.

Job Position: Guidewire Claims Business Analyst Location: Hybrid (3 days onsite) Duration: 6-12 Months Interview Type: Video    Responsibilities:      - Gather and document business requirements for Guidewire Claims system enhancements and configurations.      - Conduct User Acceptance Testing (UAT) and ensure system functionality meets business needs.      - Collaborate with stakeholders to prioritize and plan project deliverables.      - Facilitate workshops and meetings to elicit requirements and resolve issues.      - Provide ongoing support and training to end-users on Guidewire Claims functionalities.     Requirements:      - Strong understanding of Guidewire Claims system and its modules.      - Experience with Software Development Life Cycle (SDLC) and Agile methodologies.      - Ability to communicate effectively with both technical and non-technical stakeholders.      - Detail-oriented with strong analytical and problem-solving skills. Benefits:      - In house training      - Professional development opportunities      - Dynamic and collaborative work environment      - H1B Processing (EMPLOYMENT SPONSORSHIP AVAILABLE)      - Candidate MUST BE Authorized to work in the United States      - Contract to PERM role OPT / STEM OPT / H1 / H4 EAD / GC / USC all welcomed to apply We Won’t work on C2C for GC and USC. If you meet the qualifications and are interested, please DM with your updated resume. Thank you for considering this opportunity. We look forward to the possibility of you joining our team and contributing to our strategic objectives.