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QC Lab Technician 2

In Georgia / United States

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QC Lab Technician 2   

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JOB TITLE:

QC Lab Technician 2

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Exton Pennsylvania Georgia / United States

JOB DESCRIPTION:

Description:

1. General Job Information Job Title: Analytical QC Technician II Business
Unit: client Biomedical Department: Quality and Regulatory Assurance

3. Purpose of the Job

Reporting to the Product Quality Supervisor, the Analytical QC Technician II supports the

accurate and timely testing and inspection of current products lines in their area of

responsibility following customer requirements and/or established procedures. Analytical

QC Technician II works with all areas of Operations and R&D in order ensure that client

products are of consistent and high quality by: conducting standard and non-routine

laboratory tests, performing product inspections, and organizing data in a manner compliant

GMPs.

4. Job Context

client Biomedical is the world’s unrivaled biomaterials expert and committed partner in driving

sustainable innovation in healthcare. For more than 30 years, the company has been at the

forefront of biomaterial science and process innovation, and the leading resource for global

medical device and pharmaceutical companies. As a strategic partner with an approach driven

not only by market dynamics but by the unique needs of every customer, client Biomedical brings

an unparalleled breadth of product portfolios, proprietary manufacturing and processing

capabilities, world-class IP, and extensive regulatory experience and expertise. Furthermore,

client Biomedical’s products and services are recognized for their unmatched quality,

consistency, and performance in multiple markets across the globe, supporting their company-

wide vision of solving the world’s healthcare needs through sustainable science. To learn more,

visit client .com.

5. Job Content

a) Key Areas of Accountability / Responsibility:
1. Conduct laboratory tests and inspections on raw materials, in-process, and finished products.
2. Analyze and maintain all test data according to cGMPs. 3. Conduct thorough batch record reviews as part of material approval process.
4. Initiate NCRs as needed and execute the final disposition, including MRB transactions.
5. Organize laboratory supplies and documentation.
6. Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.
7. Perform routine equipment maintenance and calibration on equipment.
8. Conduct routine environmental monitoring on controlled areas and water systems.
9. Offer suggestions on improvement of methods and implement through change control process.
10. Perform non-routine tests involved with method development/improvement, process optimization studies, and validation and qualification projects.
11. Assist the Biomaterials Manufacturing and R&D teams as needed.
12. Perform other duties as assigned.
13. Adhere to client Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards. Complexity of Tasks: Basic to complex Independent Judgment: Some latitude for independent judgment Extent of Supervision: Works under moderate supervision The Analytical QC Technician II is the second level technician within the QC Laboratory. The Analytical QC Technician II functions at a higher level than a Technician I with less supervision and more latitude for independent judgement. The Technician II has a better understanding of testing methods and is capable of performing a wider variety of testing methods and tasks. This would include basic instrument and results troubleshooting. The Technician II is expected to have good interpersonal skills and must function well in a team environment. The Technician II is expected to lead by example to Jr. Technicians and is expected to present themselves with professionalism.
b) Authorities: 1. Acceptance and Rejection of raw materials, components, and finished product per written specifications and drawings.
c) Project Management or Special Assignments:

Internally client Biomedical Assist process engineering and manufacturing of new products by providing inspection data for these R&D projects in order to gage client capability of process to manufacture parts desired by a customer. Support process improvement initiatives in accordance with client Biomedical Continuous Improvement Program. SHE & Security · Acts in such a way that the organization will learn from its incidents. Incidents will be investigated, possible improvements (and incidents) are reported and the risks of the work are assessed regularly/routinely. · Encourages colleagues and management to improve SHE results and prevent incidents. · It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. · Complies with all job-related safety, security and other training requirements. · Assist in insuring that SHE regulations are in place and followed upon by making SHE a regular subject of discussion in team meetings and holding employees accountable for their SHE behavior/attitude. · Supports and enforces the policy of reporting incidents, possible SHE incidents and improvement possibilities and checks that the work is routinely assessed. · Assists in insuring that Security regulations and facilities are in place and followed upon and correctly used by monitoring this and making a Security a regular subject of discussion in team meetings and holding employees accountable for their Security behavior/attitude. · Assists and supports management in ensuring employees know what they are required to know and can do, to perform their job in a (SHE) responsible way · Supports management in ensuring that all procedures and instructions for the job are workable with safety analysis and followed by routine observation and auditing employees under his/her supervision. • Conducts periodical and non-periodical inspection. • Facilitates and implements continuous work method improvement. • Formulates standard operational procedure (SOP). • Comply with client Life Saving Rules

6. Complexity of the Job

· Will work primarily in QC laboratories and manufacturing clean rooms.

· Must follow all safety regulations including the wearing of appropriate attire (lab coat,

gloves, goggles, mask, respirator etc.).

· May be required to work with toxic and/or caustic chemicals, or other hazardous

materials. · May be required to write/revise test method SOPs. · QC Laboratory function at client Biomedical Exton encompasses all QC Inspector responsibilities but within the context of a laboratory that is responsible for analytical and mechanical testing of biomaterials based products. · The laboratory function requires versatile and competent personnel who can shift among a varied set of functions and tests, and learn scientific principles as new products and test methods are developed and transferred to QC. · Tests in the laboratory cover a wide scope of scientific fields supporting multiple product lines (lists not exhaustive): 1. Microbiology (e.g. Endotoxin, Bioburden, Environmental Monitoring) 2. Wet Chemistry (e.g. Titrations, Moisture Testing, UV-VIS assays, Kjelhdahl Nitrogen, Hexanes, IV) 3. Spectral & Dry Chemistry (e.g. FTIR, XRD, PSD, Porosity, DSC, Ash Content, Solids) 4. Analytical Chemistry / Chromatography (e.g. GC, SEC, HPLC) 5. Bioanalytical (e.g. DNA Quantification, Micro-BCA, Blyscan) 6. Mechanical Testing (e.g. Suture pulls, Wet Tear, Compression, Injection) · The technician should have good fundamental understanding of their assigned tests and can ascertain the validity of test results. · The position also requires supporting the development work required for updating test methods for reasons such as automation to increase efficiency, instrument changeout due to end-of-life, software upgrades, or implementing alternate methods.

7. Knowledge and Educational Level

· Associates degree in the biological or chemical sciences required. BS degree preferred.

Years of experience may be substituted for degree.

8. Required Level of Experience

·Minimum 0-3 years of experience demonstrating progressive inspection and testing.

responsibilities in a laboratory setting

·Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment

·Knowledge of commonly used concepts, practices, and procedures within a QC

environment

·Basic knowledge & understanding of sampling techniques (ANSI/ASQC Z1.4-2003)

·Must have excellent writing, editing and proofing skills

·Proficient using MS Word, Excel and Outlook

Position Details

POSTED:

Jun 25, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16506684116622283

LOCATION:

Georgia / United States

CITY:

Exton Pennsylvania

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

QC Lab Technician 2    Apply

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Description:

1. General Job Information Job Title: Analytical QC Technician II Business
Unit: client Biomedical Department: Quality and Regulatory Assurance

3. Purpose of the Job

Reporting to the Product Quality Supervisor, the Analytical QC Technician II supports the

accurate and timely testing and inspection of current products lines in their area of

responsibility following customer requirements and/or established procedures. Analytical

QC Technician II works with all areas of Operations and R&D in order ensure that client

products are of consistent and high quality by: conducting standard and non-routine

laboratory tests, performing product inspections, and organizing data in a manner compliant

GMPs.

4. Job Context

client Biomedical is the world’s unrivaled biomaterials expert and committed partner in driving

sustainable innovation in healthcare. For more than 30 years, the company has been at the

forefront of biomaterial science and process innovation, and the leading resource for global

medical device and pharmaceutical companies. As a strategic partner with an approach driven

not only by market dynamics but by the unique needs of every customer, client Biomedical brings

an unparalleled breadth of product portfolios, proprietary manufacturing and processing

capabilities, world-class IP, and extensive regulatory experience and expertise. Furthermore,

client Biomedical’s products and services are recognized for their unmatched quality,

consistency, and performance in multiple markets across the globe, supporting their company-

wide vision of solving the world’s healthcare needs through sustainable science. To learn more,

visit client .com.

5. Job Content

a) Key Areas of Accountability / Responsibility:
1. Conduct laboratory tests and inspections on raw materials, in-process, and finished products.
2. Analyze and maintain all test data according to cGMPs. 3. Conduct thorough batch record reviews as part of material approval process.
4. Initiate NCRs as needed and execute the final disposition, including MRB transactions.
5. Organize laboratory supplies and documentation.
6. Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.
7. Perform routine equipment maintenance and calibration on equipment.
8. Conduct routine environmental monitoring on controlled areas and water systems.
9. Offer suggestions on improvement of methods and implement through change control process.
10. Perform non-routine tests involved with method development/improvement, process optimization studies, and validation and qualification projects.
11. Assist the Biomaterials Manufacturing and R&D teams as needed.
12. Perform other duties as assigned.
13. Adhere to client Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards. Complexity of Tasks: Basic to complex Independent Judgment: Some latitude for independent judgment Extent of Supervision: Works under moderate supervision The Analytical QC Technician II is the second level technician within the QC Laboratory. The Analytical QC Technician II functions at a higher level than a Technician I with less supervision and more latitude for independent judgement. The Technician II has a better understanding of testing methods and is capable of performing a wider variety of testing methods and tasks. This would include basic instrument and results troubleshooting. The Technician II is expected to have good interpersonal skills and must function well in a team environment. The Technician II is expected to lead by example to Jr. Technicians and is expected to present themselves with professionalism.
b) Authorities: 1. Acceptance and Rejection of raw materials, components, and finished product per written specifications and drawings.
c) Project Management or Special Assignments:

Internally client Biomedical Assist process engineering and manufacturing of new products by providing inspection data for these R&D projects in order to gage client capability of process to manufacture parts desired by a customer. Support process improvement initiatives in accordance with client Biomedical Continuous Improvement Program. SHE & Security · Acts in such a way that the organization will learn from its incidents. Incidents will be investigated, possible improvements (and incidents) are reported and the risks of the work are assessed regularly/routinely. · Encourages colleagues and management to improve SHE results and prevent incidents. · It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. · Complies with all job-related safety, security and other training requirements. · Assist in insuring that SHE regulations are in place and followed upon by making SHE a regular subject of discussion in team meetings and holding employees accountable for their SHE behavior/attitude. · Supports and enforces the policy of reporting incidents, possible SHE incidents and improvement possibilities and checks that the work is routinely assessed. · Assists in insuring that Security regulations and facilities are in place and followed upon and correctly used by monitoring this and making a Security a regular subject of discussion in team meetings and holding employees accountable for their Security behavior/attitude. · Assists and supports management in ensuring employees know what they are required to know and can do, to perform their job in a (SHE) responsible way · Supports management in ensuring that all procedures and instructions for the job are workable with safety analysis and followed by routine observation and auditing employees under his/her supervision. • Conducts periodical and non-periodical inspection. • Facilitates and implements continuous work method improvement. • Formulates standard operational procedure (SOP). • Comply with client Life Saving Rules

6. Complexity of the Job

· Will work primarily in QC laboratories and manufacturing clean rooms.

· Must follow all safety regulations including the wearing of appropriate attire (lab coat,

gloves, goggles, mask, respirator etc.).

· May be required to work with toxic and/or caustic chemicals, or other hazardous

materials. · May be required to write/revise test method SOPs. · QC Laboratory function at client Biomedical Exton encompasses all QC Inspector responsibilities but within the context of a laboratory that is responsible for analytical and mechanical testing of biomaterials based products. · The laboratory function requires versatile and competent personnel who can shift among a varied set of functions and tests, and learn scientific principles as new products and test methods are developed and transferred to QC. · Tests in the laboratory cover a wide scope of scientific fields supporting multiple product lines (lists not exhaustive): 1. Microbiology (e.g. Endotoxin, Bioburden, Environmental Monitoring) 2. Wet Chemistry (e.g. Titrations, Moisture Testing, UV-VIS assays, Kjelhdahl Nitrogen, Hexanes, IV) 3. Spectral & Dry Chemistry (e.g. FTIR, XRD, PSD, Porosity, DSC, Ash Content, Solids) 4. Analytical Chemistry / Chromatography (e.g. GC, SEC, HPLC) 5. Bioanalytical (e.g. DNA Quantification, Micro-BCA, Blyscan) 6. Mechanical Testing (e.g. Suture pulls, Wet Tear, Compression, Injection) · The technician should have good fundamental understanding of their assigned tests and can ascertain the validity of test results. · The position also requires supporting the development work required for updating test methods for reasons such as automation to increase efficiency, instrument changeout due to end-of-life, software upgrades, or implementing alternate methods.

7. Knowledge and Educational Level

· Associates degree in the biological or chemical sciences required. BS degree preferred.

Years of experience may be substituted for degree.

8. Required Level of Experience

·Minimum 0-3 years of experience demonstrating progressive inspection and testing.

responsibilities in a laboratory setting

·Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment

·Knowledge of commonly used concepts, practices, and procedures within a QC

environment

·Basic knowledge & understanding of sampling techniques (ANSI/ASQC Z1.4-2003)

·Must have excellent writing, editing and proofing skills

·Proficient using MS Word, Excel and Outlook


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