Quality Control Snr Associate

3 weeks ago

india PSC Biotech Ltd Full time
Job Description

About PSC Biotech

 

Who we are?

 

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

‘Take your Career to a new Level’

 

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 


Employee Value Proposition

 

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

 


Quality Control Snr Associate

 

Job Summary:

 

·        Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

·        Contributes to team by ensuring the quality of the tasks/services provided by self

·        Contributes to the completion of milestones associated with specific projects or activities within team.

·        This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.


Requirements

Primary Responsibilities:

·        QC Representative for NPI activities and routine Product meetings

·        Assist with activities related to QC projects and/or QC tasks within Site projects.

·        Plan and perform non-core testing related to NPI activities.

·        Manage all sample management activities related to NPI activities throughout the site.

·        Create/own and approve protocols, sample plans, SOP and documentation related to NPI.

·        QC Representative responsible for Method Validation and Transfers co-ordination and readiness

·        Responsible for their own training and safety compliance.

·        Sample shipments and temperature monitoring activities for NPI activities.

·        LIMS data coordination of non-core (NPI) activities.

 

Specific Job Duties:

 

·        With a high degree of technical flexibility, work across diverse areas within QC

·        Plan and perform analyses with great efficiency and accuracy.

·        Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

·        Report, evaluate, back-up/archive, trend and approve analytical data.

·        Troubleshoot, solve problems, and communicate with stakeholders.

·        Initiate and/or implement changes in controlled documents.

·        May train others as necessary

·        Participate in audits, initiatives and projects that may be departmental or organizational in scope.

·        Write protocols and perform assay validation and equipment qualification/ verification.

·        Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.

·        May contribute to regulatory filings.

·        May conduct lab investigations as necessary.

·        Evaluate lab practices for compliance on a continuous basis.

·        Approve lab results.

·        May represent the department/organization on various teams.

·        May interact with outside resources.

·        Create APPX data files and randomisation memo to facilitate data analysis.

·        LIMS data coordination of commercial and import testing on site where applicable.

·        May provide technical guidance. May contribute to regulatory filings.

·        May represent the department/organization on various teams. May train others.

·        May interact with outside resources.

 

Basic Qualifications & Experience:

 

Qualifications:

 

·        Bachelor’s degree in a science discipline.

·        2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

·        Strong background in Chemistry and Analytical testing is required.

·        Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

 

Knowledge:

 

·        Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories.  Deepens technical knowledge through exposure and continuous learning.

·        Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

 

Problem Solving:

 

·        Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information.

·        Qualitative information

·        Quantitative research

·        Trend data

·        Anticipates and prevents potential problems.

 

Skills:

 

·        Take initiative to identify and drive improvements.

·        Communication skills (verbal and written) at all levels.

·        Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

·        Presentation skills

·        Escalate issues professionally and on a timely basis.

·        Decision making

·        Teamwork and Coaching others

·        Teamwork and Coaching others

·        Auditing documentation and operation process

 

Competencies:

·        Demonstrated ability to work independently and deliver right first-time results

·        Works under minimal direction

·        Work is guided by objectives of the department or assignment.

·        Follows procedures.

·        Refers to technical standards, principles, theories, and precedents as needed.

·        May set project timeframes and priorities based on project objectives and ongoing assignments.

·        Recognizes and escalates problems.

·        Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues.

·        Auditing documentation and operation process

·        Demonstrated ability to interact with regulatory agencies.

 

Relevant experience:

 

·        Bachelor’s degree in a Science related field is required.

·        5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,

·        Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. 


#LI-KV1


Requirements
Primary Responsibilities: · QC Representative for NPI activities and routine Product meetings · Assist with activities related to QC projects and/or QC tasks within Site projects. · Plan and perform non-core testing related to NPI activities. · Manage all sample management activities related to NPI activities throughout the site. · Create/own and approve protocols, sample plans, SOP and documentation related to NPI. · QC Representative responsible for Method Validation and Transfers co-ordination and readiness · Responsible for their own training and safety compliance. · Sample shipments and temperature monitoring activities for NPI activities. · LIMS data coordination of non-core (NPI) activities. Specific Job Duties: · With a high degree of technical flexibility, work across diverse areas within QC · Plan and perform analyses with great efficiency and accuracy. · Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. · Report, evaluate, back-up/archive, trend and approve analytical data. · Troubleshoot, solve problems, and communicate with stakeholders. · Initiate and/or implement changes in controlled documents. · May train others as necessary · Participate in audits, initiatives and projects that may be departmental or organizational in scope. · Write protocols and perform assay validation and equipment qualification/ verification. · Introduce new techniques to the lab, including method transfers, reports, validations, and protocols. · May contribute to regulatory filings. · May conduct lab investigations as necessary. · Evaluate lab practices for compliance on a continuous basis. · Approve lab results. · May represent the department/organization on various teams. · May interact with outside resources. · Create APPX data files and randomisation memo to facilitate data analysis. · LIMS data coordination of commercial and import testing on site where applicable. · May provide technical guidance. May contribute to regulatory filings. · May represent the department/organization on various teams. May train others. · May interact with outside resources. Basic Qualifications & Experience: Qualifications: · Bachelor’s degree in a science discipline. · 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. · Strong background in Chemistry and Analytical testing is required. · Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Knowledge: · Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning. · Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Problem Solving: · Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information. · Qualitative information · Quantitative research · Trend data · Anticipates and prevents potential problems. Skills: · Take initiative to identify and drive improvements. · Communication skills (verbal and written) at all levels. · Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) · Presentation skills · Escalate issues professionally and on a timely basis. · Decision making · Teamwork and Coaching others · Teamwork and Coaching others · Auditing documentation and operation process Competencies: · Demonstrated ability to work independently and deliver right first-time results · Works under minimal direction · Work is guided by objectives of the department or assignment. · Follows procedures. · Refers to technical standards, principles, theories, and precedents as needed. · May set project timeframes and priorities based on project objectives and ongoing assignments. · Recognizes and escalates problems. · Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues. · Auditing documentation and operation process · Demonstrated ability to interact with regulatory agencies. Relevant experience: · Bachelor’s degree in a Science related field is required. · 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, · Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. #LI-KV1

  • Quality Assurance Associate

    2 months ago

    india Marken Full time

    Description Title:   Quality Assurance Associate  Job Title: Quality Assurance Associate Job Purpose: The Quality Assurance Associate is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control...

  • Quality Control Specialist

    3 weeks ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech  Who we are?   PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...

  • Quality Control engineer

    2 weeks ago

    india Sisco Jobs Full time

    Job Description Position - Quality Control engineer Experience - 5 years Salary - 23,000 to 27,000 Bachler Accommodation + Food - company's scope (free of cost) Location - Yercard Qualification - Diploma or BE in civilPosition Overview: As a Quality Control Engineer, you will be responsible for ensuring that construction projects adhere to quality standards...

  • Quality Control Inspector I

    2 weeks ago

    india Trendsetter Engineering, Inc. Full time

    Job Description Summary: The Quality Control Inspector 1 supports the organization in the development, maintenance and execution of a quality control program that will allow the business to continually improve. In addition, the Quality Control Inspector 1 will help ensure that the supply being delivered from vendors and the product being shipped to customers...

  • Executive - Quality Control

    4 days ago

    India Piramal Enterprises Full time

    Business: PPL Digwal Department: Quality Control Location: Digwal Job Overview: To perform Quality Control actives as per GMP & Safety Travel Requirements: NA Reporting Structure: Reports to Manager - QC Key Stakeholders: Internal: Production, QA, SCM, IT, Engineering & Maintenance, TSD & Safety External: Customers Experience: - 4-8 Year...

  • Quality Control Engineer

    1 month ago

    india Tatmeem Private Limited Full time

    Ideal candidate should meet the following criteria BE Mechanical should have 3 - 5 years work experience as quality control engineer with industrial valves manufacturing sector. Developing and implementing quality control procedures to identify defects or deviations in the manufacturing process. Conducting regular inspections and audits of production lines...

  • PING Consultant

    1 week ago

    india XPT Software Australia Pty Ltd Full time

    Job Description Role: PING Consultant  Total and Relevant Years of experience: 4+ years 1.      Good understanding of PING & how it is integrated in Digital/ELZ platform in diff patterns : Proxy, Browser hand-off, Server-To-Server, Third party etc.2.      To be able to deliver high level design (Solution on a page)3.      To be able to do...

  • Quality Control Manager

    2 months ago

    india Talent Corner Full time

    Roles and Responsibilities   Experience: 5+Location: BhiwandiBachelor's degree in a relevant field (e.g., engineering, quality management).Strong knowledge of quality management systems, quality control tools, and industry-specific regulations. Desired Candidate Profile   Perks and Benefits  

  • Engr, IT Quality Control

    4 days ago

    india Cardinal Health Full time

    Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value.Quality Control analyzes and inspects Information Technology products and processes for...

  • Associate Quality Specialist

    2 weeks ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech     Who we are?  PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...

  • Vehicle Quality Control Inspector

    3 weeks ago

    india TH Consultants Recruitment Specialists Ltd Full time

    Job Description Our Client is a well-established Commercial Bodyshop based in the Ashford area of Greater London. An excellent opportunity has arisen for an experienced Vehicle Quality Control Inspector, who enjoys working in a fast-paced environment to join their team. You must have previous experience working in a vehicle repair centre and are confident...

  • Quality Control Supervisor

    3 weeks ago

    india Hirearchy, LLC Full time

    Job Description Reporting to the Production Manager, the Quality Control Supervisor directs his/her workforce in a safe and efficient manner consistent with the Company philosophy in order to achieve production levels within budget cost.Check and improve all optimized machine centersCheck, report, and improve mill product distribution and flowMonitor...

  • Manager, Quality Control

    18 hours ago

    india Talent Consulting Experts Full time

    Job Description Join Our Team as a Manager, Quality Control!Are you an experienced Quality Control professional with a passion for excellence in the ASME manufacturing sector? We are seeking a dedicated Manager, Quality Control to lead our team and ensure our quality programs and systems meet or exceed customer and industry standards.Key...

  • Manager, Quality Control

    3 weeks ago

    india Talent Consulting Experts Full time

    Job Description Join our Quality Assurance team in Fenton, MO, as a Manager of Quality Control, where you will spearhead the implementation of our rigorous quality programs and systems. This role is crucial in ensuring our engineering outputs meet or exceed both customer-specific and industry-wide standards, thereby enhancing our market reputation for...

  • Quality Control Manager – Fort Johnson, LA

    2 weeks ago

    india Burgos Group Full time

    Job Description Burgos Group is currently seeking a Construction Quality Control Manager to work on a Federal heavy civil engineering project at Fort Johnson, LA.  Travel expenses will be reimbursed.  We are looking for an experienced Quality Control Manager to ensure that our services meet all necessary client requirements.  Must be able to pass a...

  • Sr Analyst, IT Quality Control

    5 days ago

    india Cardinal Health Full time

    Sr Analyst, IT Quality Control About Us: Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and...

  • Associate Quality Assurance Specialist

    2 weeks ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Manager, Quality Control

    6 days ago

    india Talent Consulting Experts Full time

    Job Description We are seeking a Manager, Quality Control with extensive experience in quality assurance within the ASME manufacturing sector. This role is based in Fenton, MO, and involves leading a team responsible for ensuring that our quality programs and systems meet or exceed customer and industry requirements.Key Responsibilities:Analyze quality...

  • Sr. Engineer/ Asst. Manager

    2 weeks ago

    india Alcop Industries Full time

    We're looking for below positions preferably from the wire and cable industry. Position : Sr. Engineer/ Asst. Manager - Quality Control Industry : Wires, Cables & Harness manufacturing Experience : 5 to 7 Years Qualification : B.E/B.Tech or equivalent degree Managing Quality Control From Raw Materials to Finish Products Technical Knowledge of Wire and...

  • Associate, Compliance

    9 hours ago

    India BNY Mellon Full time

    **Overview** Associate, Compliance & Control II **Bring your ideas. Make history.** BNY Mellon offers an exciting array of future-forward careers at the intersection of business, finance, and technology. We are one of the world's top asset management and banking firms that manages trillions of dollars in assets, custody and/or administration. Known as the...