QCA Validation Technician
Telford, PA Telford, PA Full-time Full-time Estimated:
$37.
3K - $47.
2K a year Estimated:
$37.
3K - $47.
2K a year 13 days ago 13 days ago 13 days ago Who we are:
The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania.
Secant provides innovative solutions through next-generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace and energy markets.
What we're looking for:
The QCA Validation Technician coordinates and implements various activities for the compliant and effective support of the Secant Group Environmental Monitoring, Routine Monitoring as it relates to Quality Control functions in support of ISO 13485, internal/customer compliance, and clean room requirements.
Also responsible for performing various laboratory assays, testing to support plant operations, utility/EM sampling and validation.
What you'll do:
Coordinates, implements, and supports activities related to the support of Secant Group (SG) Environmental Monitoring of ISO 7 and ISO 8 clean rooms including the sampling, testing, data reporting, CAPA and failure remediation and Work Instruction/SOP updates as required.
Coordinates, implements, and supports activities related to the management of SG Routine Monitoring for validated utilities (N2, Clean Dry Air, and DI Water) including the sampling, testing, data reporting, CAPA and failure remediation and Work Instruction/SOP updates as required.
Supports investigation activities concerning OOS failures, CAPA/Nonconformance events, coordinates/performs testing, and generates test reports for engineering evaluations, corrective actions, DOEs, etc.
Provides technical support for additional quality systems and functional areas as needed and/or assigned including, but not limited to Preventive/Unscheduled Maintenance and Calibration, Validation, Training, Research & Development, and Product/Process Development, Manufacturing and Quality Engineering groups.
Performs equipment qualifications and utility performance qualifications as required.
Participates in special company and corporate initiatives and projects as needed and assigned.
Other Duties Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.
g.
, SOP's, Work Instructions) to successfully accomplish job requirements.
Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
Follows gowning procedures in designated areas.
Follows established safety requirements and adheres to the Health Safety and Environment Management System.
Performs other job-related responsibilities as assigned.
Who you are:
Bachelor's degree in Biology, Chemistry or related scientific field with 0-3 years' experience or High School Diploma plus minimum 2-3 years' experience.
0-3 prior experience in a regulated life science industry (e.
g.
, Medical Device, Pharmaceutical) in one or more of the following functions:
Quality Control, Quality Assurance, Research and Development, Analytical Laboratory, Validation.
Hands-on experience with analytical lab equipment preferred (TOC, Conductivity/pH Meter).
Ability to understand the working mechanisms, methodologies, and general interpretation of testing results.
1-3 years of experience in a related industry or regulated environment preferred but not required (e.
g.
, ISO 9001, ISO 13485, 21 CFR Part 820).
Intermediate to advanced knowledge of MS Office Suite.
Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignment; Strong problem solving and organizational skills.
Demonstrated ability to organize and manage small to medium-sized projects and effectively participate in cross-functional teams.
Strong written and verbal communication skills with the ability to collaborate effectively with professionals from various engineering, production, and research disciplines.
Why join us:
We promote a collaborative, high energy, and fast-paced environment.
Using fact-based data, our team members strive to constantly improve our processes and products.
We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.
What we offer:
Health Insurance:
Medical with Rx plan / Dental / Vision 401k (retirement savings) with excellent company match Profit Sharing Plan Company Paid Short-Term and Long-Term Disability Year-End Incentive Plans Generous Paid Time off Holiday Pay Secant Group is an Equal Opportunity Employer.
We maintain a commitment to providing equal access to employment.
We value diversity and encourage applications from all genders, members of minority groups, LGBTQ individuals, veterans, and disabled individuals.
Secant Group is a drug-free workplace.
All offers of employment are contingent on passing a drug screen as well as a background investigation (including a criminal courts history, driving record report if applicable, and social security name and number verification).
The company provides reasonable accommodations for disabilities.
Secant Group participates in E-Verify as appropriate in accordance with company guidelines and federal or state law.
This includes providing the Social Security Administration and, if necessary, the Department of Homeland Security, with information from each new employee's Form I-9 to confirm work authorization.
Secant Group's Telford, PA, location is a smoke-free campus.
Smoking is not permitted in or around the building, including in vehicles.
Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Tuition reimbursement Vision insurance Experience level:
Under 1 year Schedule:
8 hour shift Day shift Monday to Friday Work setting:
In-person Manufacturing facility Application Question(s):
Please list the analytical lab equipment you have used.
Education:
Bachelor's (Preferred)
Experience:
Laboratory:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
$37.
3K - $47.
2K a year Estimated:
$37.
3K - $47.
2K a year 13 days ago 13 days ago 13 days ago Who we are:
The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania.
Secant provides innovative solutions through next-generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace and energy markets.
What we're looking for:
The QCA Validation Technician coordinates and implements various activities for the compliant and effective support of the Secant Group Environmental Monitoring, Routine Monitoring as it relates to Quality Control functions in support of ISO 13485, internal/customer compliance, and clean room requirements.
Also responsible for performing various laboratory assays, testing to support plant operations, utility/EM sampling and validation.
What you'll do:
Coordinates, implements, and supports activities related to the support of Secant Group (SG) Environmental Monitoring of ISO 7 and ISO 8 clean rooms including the sampling, testing, data reporting, CAPA and failure remediation and Work Instruction/SOP updates as required.
Coordinates, implements, and supports activities related to the management of SG Routine Monitoring for validated utilities (N2, Clean Dry Air, and DI Water) including the sampling, testing, data reporting, CAPA and failure remediation and Work Instruction/SOP updates as required.
Supports investigation activities concerning OOS failures, CAPA/Nonconformance events, coordinates/performs testing, and generates test reports for engineering evaluations, corrective actions, DOEs, etc.
Provides technical support for additional quality systems and functional areas as needed and/or assigned including, but not limited to Preventive/Unscheduled Maintenance and Calibration, Validation, Training, Research & Development, and Product/Process Development, Manufacturing and Quality Engineering groups.
Performs equipment qualifications and utility performance qualifications as required.
Participates in special company and corporate initiatives and projects as needed and assigned.
Other Duties Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.
g.
, SOP's, Work Instructions) to successfully accomplish job requirements.
Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
Follows gowning procedures in designated areas.
Follows established safety requirements and adheres to the Health Safety and Environment Management System.
Performs other job-related responsibilities as assigned.
Who you are:
Bachelor's degree in Biology, Chemistry or related scientific field with 0-3 years' experience or High School Diploma plus minimum 2-3 years' experience.
0-3 prior experience in a regulated life science industry (e.
g.
, Medical Device, Pharmaceutical) in one or more of the following functions:
Quality Control, Quality Assurance, Research and Development, Analytical Laboratory, Validation.
Hands-on experience with analytical lab equipment preferred (TOC, Conductivity/pH Meter).
Ability to understand the working mechanisms, methodologies, and general interpretation of testing results.
1-3 years of experience in a related industry or regulated environment preferred but not required (e.
g.
, ISO 9001, ISO 13485, 21 CFR Part 820).
Intermediate to advanced knowledge of MS Office Suite.
Detail-oriented, self-starter with high attention to detail and ability to work on and coordinate multiple projects/assignment; Strong problem solving and organizational skills.
Demonstrated ability to organize and manage small to medium-sized projects and effectively participate in cross-functional teams.
Strong written and verbal communication skills with the ability to collaborate effectively with professionals from various engineering, production, and research disciplines.
Why join us:
We promote a collaborative, high energy, and fast-paced environment.
Using fact-based data, our team members strive to constantly improve our processes and products.
We nurture an environment where employees can creatively innovate solutions that drive impactful results both for the business and themselves.
What we offer:
Health Insurance:
Medical with Rx plan / Dental / Vision 401k (retirement savings) with excellent company match Profit Sharing Plan Company Paid Short-Term and Long-Term Disability Year-End Incentive Plans Generous Paid Time off Holiday Pay Secant Group is an Equal Opportunity Employer.
We maintain a commitment to providing equal access to employment.
We value diversity and encourage applications from all genders, members of minority groups, LGBTQ individuals, veterans, and disabled individuals.
Secant Group is a drug-free workplace.
All offers of employment are contingent on passing a drug screen as well as a background investigation (including a criminal courts history, driving record report if applicable, and social security name and number verification).
The company provides reasonable accommodations for disabilities.
Secant Group participates in E-Verify as appropriate in accordance with company guidelines and federal or state law.
This includes providing the Social Security Administration and, if necessary, the Department of Homeland Security, with information from each new employee's Form I-9 to confirm work authorization.
Secant Group's Telford, PA, location is a smoke-free campus.
Smoking is not permitted in or around the building, including in vehicles.
Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Referral program Tuition reimbursement Vision insurance Experience level:
Under 1 year Schedule:
8 hour shift Day shift Monday to Friday Work setting:
In-person Manufacturing facility Application Question(s):
Please list the analytical lab equipment you have used.
Education:
Bachelor's (Preferred)
Experience:
Laboratory:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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