GxP Quality Auditor / Sr Quality Lead
Greenville, NC jobs
GxP Quality Auditor / Senior Quality Lead
Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year
A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity.
Position Summary
The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment.
Key Responsibilities
Coordinate between site and global teams to align SOPs and bracketing strategy
Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements
Develop and defend bracketing justification for multiple manufacturing lines and isolators
Facilitate governance meetings, escalate risks, and report status to leadership
Review and approve protocol templates, summaries, and reports for finalization
Qualifications
Bachelor's degree in a scientific or industry-related field
Minimum 7+ years of experience in pharmaceutical manufacturing or compliance
Proven experience developing bracketing and matrixing strategies
Strong knowledge of FDA, EMA, and HMRA regulations
Familiarity with cGMP and facility/equipment validation requirements
Excellent technical writing and communication skills
Ability to work full-time on-site in Greenville, NC
Why Join This Team?
Competitive compensation and performance-based incentives
Comprehensive benefits package including medical, dental, vision, and retirement plans
Paid time off, holidays, and professional development opportunities
Collaborative culture with strong career growth potential
Laboratory Technician
Plaquemine, LA jobs
We are looking for a dedicated and passionate individual to join our team as a Laboratory Technician in our METHOCELTM Quality Control lab in Plaquemine, LA. In this role you will be responsible for performing routine analyses, evaluating results, and calibrating and maintaining analytical systems to provide analytical data to produce and release products including Pharmaceutical Excipients and Industrial Specialty products.
The ideal candidate will have:
Β· Relevant laboratory experience. (Experience with biology, bioscience, biotechnology, biochemistry, chemistry, or aseptic techniques is a plus.)
Β· Can demonstrate mechanical aptitude and problem-solving skills.
Β· Strong written and verbal communication skills plus ability to work and collaborate with a team.
Β· Basic computer skills. (Experience with computer-based systems such as LIMS, Electronic Logbook, etc. is a plus.) Strong sense of self-motivation and ability to work under minimal supervision.
Β· Ability to prioritize and troubleshoot issues under pressure.
Β· Strong initiative, ability to work independently and the ability to multi-task.
Β· Strong interpersonal skills, allowing them to work with a variety of roles within the manufacturing plant and analytical organization.
Β· Must be able to work and interact effectively as a member of a team.
Β· Must have the ability to learn and apply technical concepts related to laboratory instruments, sample analyses and data interpretation.
Β· Bachelor's degree in a technical or science field desired. 20 hours College Chemistry or relevant work experience is required.
Job Requirements
Β· Follow procedures related to EH&S and to the Analytical Work Process
Β· Adhere to good laboratory practices
Β· Adhere to cGMP and good documentation practices requirements.
Β· Perform routine analyses according to documented procedures
Β· Evaluate correctness of data
Β· Document and communicate laboratory results
Quality Assurance Tech
Lynwood, CA jobs
PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.
The Quality Assurance Technician is responsible for ensuring that products or services consistently meet defined quality standards and customer requirements. They perform inspections, tests, and evaluations to identify and resolve quality issues, contributing to the overall quality of the production process.
JOB QUALIFICATIONS:
High School Diploma or equivalent required
2-5 years of experience in related field
Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210 & 211 preferred
Highly organized and strong attention to detail
Time management skills and ability to handle multiple tasks on time
Excellent oral and written communication skills in English
Proficient in Word and Excel
Working knowledge of Oracle and Agile preferred
Experience with Warehouse Management Systems (WMS)
Must be able to drive a forklift, training offered
POSITION RESPONSIBILITIES:
Manage receiving inspection of all critical components and raw materials
Manage and support JIT program
Review and report all documentation from shipments prior to release in Oracle
Manage NCMR and RMA programs and oversee trailer loading or products slated for destruction
Manage physical inventory in NCMR and Quality Cages
Write and Review CRNs/NCMRs/CAPA/Investigations/Deviations as needed
Maintain the retains program and storage of retains
Perform and manage annual review of Finished Good retains
Generate reports to look for trends in inspections
Suggest solutions to management for trends when required
Work with cross-functional departments
Assist with investigations as requested
QA inquiries from other sites or vendors
Train the team on processes as needed
Assist Quality Management as needed
Physical Requirements:
Walking up to 6 hours per day
Sitting up to 2 hours per day
Occasionally lift up to 30 lbs.
Salary Range: $21.50-$22.50/hr
BENEFITS:
PLD is a proud employer offering many corporate benefits, including:
Γ’ Β Medical and Dental Benefits
Γ’ Β Vision
Γ’ Β 401K with employer match
Γ’ Β Group Life Insurance
Γ’ Β Flex Spending Accounts
Γ’ Β Paid Time Off and Paid Holidays
Γ’ Β Tuition Assistance
Γ’ Β Corporate Discount Program
Γ’ Β Opportunities to Flourish Within the Company
PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Quality Assurance Technician - 2nd shift
Piedmont, SC jobs
PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods
A Quality Technician is responsible for ensuring that products or services consistently meet defined quality standards and customer requirements. They perform inspections, tests, and evaluations to identify and resolve quality issues, contributing to the overall quality of the production process.
Work schedule: Monday - Friday 2:00pm - 10:30pm
Important: The candidates must be willing to work at our Piedmont facility during the firsts months, and then transition to 1817 E Poinsett St Ext., Greer, SC.
JOB QUALIFICATIONS
:
High School Diploma or equivalent required.
2-5 years of experience in related field.
Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210 & 211 preferred.
Highly organized and strong attention to detail.
Time management skills and ability to handle multiple tasks on time.
Excellent oral and written communication skills in English.
Proficient in Word and Excel.
Working knowledge of Oracle and Agile preferred.
Experience with Warehouse Management Systems (WMS).
Must be able to drive a forklift, training offered.
POSITION RESPONSIBILITIES:
Manage receiving inspection of all critical components and raw materials.
Manage and support JIT program.
Review and report all documentation from shipments prior to release in Oracle.
Manage NCMR and RMA programs and oversee trailer loading or products slated for destruction.
Manage physical inventory in NCMR and Quality Cages.
Write and Review CRNs/NCMRs/CAPA/Investigations/Deviations as needed.
Maintain the retains program and storage of retains.
Perform and manage annual review of Finished Good retains.
Generate reports to look for trends in inspections.
Suggest solutions to management for trends when required.
Work with cross-functional departments.
Assist with investigations as requested.
QA inquiries from other sites or vendors.
Train the team on processes as needed.
Assist Quality Management as needed.
PHYSICAL REQUIREMENTS:
Must be able to lift up to 50 lbs
Must be able to stand and/or walk for up to four (4) hours at a time
BENEFITS:
PLD is a proud employer offering many corporate benefits, including:
Γ’ Β Medical and Dental Benefits
Γ’ Β Vision
Γ’ Β 401K with employer match
Γ’ Β Group Life Insurance
Γ’ Β Flex Spending Accounts
Γ’ Β Paid Time Off and Paid Holidays
Γ’ Β Tuition Assistance
Γ’ Β Corporate Discount Program
Γ’ Β Opportunities to Flourish Within the Company
PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
#HP1
Quality Assurance Tech IV
Saint Louis, MO jobs
**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
** Summary**
The Quality Assurance Technician IV provides administrative support at a high level. They will act as a lead or mentor to more junior personnel. Minimal supervision will be required. He/She will work independently, sometimes without established procedures. This role serves as a key decision maker in the release function of product, and coordinates with various departments across the organization to meet shipping schedules. An extensive knowledge in products, raw materials, inventory planning, quality, and manufacturing and quality systems is required. A wide and comprehensive understanding of both general and specific phases of the job and their practical application to complex problems and situations ordinarily encountered while managing the release function within BPCS is required. Incumbents are assigned complex tasks, which require independent action and a high degree of initiative. This position prioritizes work for other individuals within the department.
**Job Description**
**ESSENTIAL FUNCTIONS:**
+ Primary role is to serve as a leader in Quality Assurance to facilitate the release of API, DP, ARS, intermediates and clinical supplies (R&D developed material) and to keep the release function on track with the shipping schedule.
+ Manage all aspects of the release process by engaging QA Tech II/IIIs for status, ensure resolution and priorities per shipping schedule.
+ Serve as the primary contact for inquires and scheduling in primary value stream
+ Point person for executing material release, status changes, or location changes for manufacturing / logistics and stability.
+ Participate on cross functional teams (Quality Control, Manufacturing, Marketing, & Logistics) to ensure that product/material conforms to customer, industry, & regulatory standards prior to release.
+ Expert knowledge/use of BPCS and LIMS
+ Supply certificate of analysis to customer service/shipping personnel
+ Work with production in recording correct DOM
+ Serve as a resource regarding batch record linkage for all special products
+ Prepare shipping schedule and attend meetings weekly
+ Mentor and provide training to QA Technicians in error types, issue resolution
+ Work across Value Streams (back up for other value stream)
+ Update shipping and MREL/DREL spreadsheets
+ Run retest and expiry reports and send out lot isolation forms
+ Update items in BPCS for the in process lab personnel
+ Review batch records as a backup or if required for shipping needs
**MINIMUM REQUIREMENTS:**
**Education:**
HS Diploma is required; Associates or Bachelor's degree is preferred. A four year degree in a technical field may be considered toward the minimum experience requirement.
**Experience:**
Minimum of 6-8 years of Document review and product release experience in a GMP environment is required. Proven knowledge of FDA and cGMP regulations required.
**Preferred Skills/Qualifications:**
Proficiency in MS Word and Excel. LIMS and BPCS experience required.
**Other Skills:**
+ Ability to communicate at a high level.
+ Ability to read and comprehend complex calculations and formulas.
+ Ability to focus and review batch records for an extended period of time.
+ Knowledge for GMPs for APIs.
+ Ability to quickly identify, communicate and/or resolve issues.
+ Ability to read and understand complex batch records.
+ Ability to keep batch records organized and easily retrievable at all times.
+ Good verbal and written communication skills.
+ Ability to understand and apply good documentation practices.
+ Ability to communicate at a high level with various departments and individuals across the site
+ Ability to understand complex data, utilizing database and various systems to extract and revise data within the system.
+ This role interacts with various individuals at all levels within the organization, must have the ability to prioritize request and manage work to timelines.
**COMPETENCIES:**
Action Oriented, Patience, Planning, Priority Setting, Problem Solving, and Technical Learning
**RELATIONSHIP WITH OTHERS:**
Works with Manufacturing, Supply Chain, Research & Development, Customer Service, and Quality personnel on a daily basis.
**WORKING CONDITIONS:**
+ 95% of Office environment which includes sitting for long periods of time and computer use
+ 5% of Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
**DISCLAIMER:**
_The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require_
**EEO Statement:**
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Quality Assurance Tech IV
Saint Louis, MO jobs
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
The Quality Assurance Technician IV provides administrative support at a high level. They will act as a lead or mentor to more junior personnel. Minimal supervision will be required. He/She will work independently, sometimes without established procedures. This role serves as a key decision maker in the release function of product, and coordinates with various departments across the organization to meet shipping schedules. An extensive knowledge in products, raw materials, inventory planning, quality, and manufacturing and quality systems is required. A wide and comprehensive understanding of both general and specific phases of the job and their practical application to complex problems and situations ordinarily encountered while managing the release function within BPCS is required. Incumbents are assigned complex tasks, which require independent action and a high degree of initiative. This position prioritizes work for other individuals within the department.
Job Description
ESSENTIAL FUNCTIONS:
Primary role is to serve as a leader in Quality Assurance to facilitate the release of API, DP, ARS, intermediates and clinical supplies (R&D developed material) and to keep the release function on track with the shipping schedule.
Manage all aspects of the release process by engaging QA Tech II/IIIs for status, ensure resolution and priorities per shipping schedule.
Serve as the primary contact for inquires and scheduling in primary value stream
Point person for executing material release, status changes, or location changes for manufacturing / logistics and stability.
Participate on cross functional teams (Quality Control, Manufacturing, Marketing, & Logistics) to ensure that product/material conforms to customer, industry, & regulatory standards prior to release.
Expert knowledge/use of BPCS and LIMS
Supply certificate of analysis to customer service/shipping personnel
Work with production in recording correct DOM
Serve as a resource regarding batch record linkage for all special products
Prepare shipping schedule and attend meetings weekly
Mentor and provide training to QA Technicians in error types, issue resolution
Work across Value Streams (back up for other value stream)
Update shipping and MREL/DREL spreadsheets
Run retest and expiry reports and send out lot isolation forms
Update items in BPCS for the in process lab personnel
Review batch records as a backup or if required for shipping needs
MINIMUM REQUIREMENTS:
Education:
HS Diploma is required; Associates or Bachelor's degree is preferred. A four year degree in a technical field may be considered toward the minimum experience requirement.
Experience:
Minimum of 6-8 years of Document review and product release experience in a GMP environment is required. Proven knowledge of FDA and cGMP regulations required.
Preferred Skills/Qualifications:
Proficiency in MS Word and Excel. LIMS and BPCS experience required.
Other Skills:
Ability to communicate at a high level.
Ability to read and comprehend complex calculations and formulas.
Ability to focus and review batch records for an extended period of time.
Knowledge for GMPs for APIs.
Ability to quickly identify, communicate and/or resolve issues.
Ability to read and understand complex batch records.
Ability to keep batch records organized and easily retrievable at all times.
Good verbal and written communication skills.
Ability to understand and apply good documentation practices.
Ability to communicate at a high level with various departments and individuals across the site
Ability to understand complex data, utilizing database and various systems to extract and revise data within the system.
This role interacts with various individuals at all levels within the organization, must have the ability to prioritize request and manage work to timelines.
COMPETENCIES:
Action Oriented, Patience, Planning, Priority Setting, Problem Solving, and Technical Learning
RELATIONSHIP WITH OTHERS:
Works with Manufacturing, Supply Chain, Research & Development, Customer Service, and Quality personnel on a daily basis.
WORKING CONDITIONS:
95% of Office environment which includes sitting for long periods of time and computer use
5% of Manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Auto-ApplyQuality Chemist
Englewood, OH jobs
Carry out QC lab analysis of raw materials, in process samples, final products, and project samples so that results are accurately determined in a timely manner, properly communicated to customers, and performed in accordance with the established Quality Systems based on ISO 9001, FSSC 22000/ISO 22002, and all applicable cGXP. This ensures that the manufacturing operation is well supported, and outside customers are promptly served with the correct product, quality, and information. As needed develop and validate analytical methods. Review data, processing records and or all other quality records for accuracy prior to release. Assist with Regulatory requests as it pertains to Quality Assurance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Key responsibilities include, but are not limited to the following:
Carry out all work to the appropriate Quality Standards, ISO 9001, FSSC 22000/ISO 22002, cGXPs, and API, as appropriate in each laboratory. Flag any issues as they arise.
Responsible for daily calibrations of all lab equipment and maintenance of records to the appropriate Quality Standards to ensure equipment is always ready for use.
Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, support production operators in their in-process testing, with clear and current communication with the lab manager/supervisor of issues and how they are being handled.
Recognize, investigate, and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people are kept informed or asked for guidance.
Analyze incoming raw materials, in process samples, finished goods, and project samples per the established SOPs using various instrumentation and techniques in the QC and API laboratories.
Fully functional in API testing and API data review.
Manages OOS investigations and ensures timely closure and resolution. Responsible in ensuring any CAPAs implemented were effective and monitored.
Drive the implementation of new testing methods and/or method improvments.
Primary trainer in laboratory testing and tasks.
Follows all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system is maintained, and good housekeeping is carried out.
Communicates fully with internal and external customers so that their requirements and results are fully understood, and any interpretation of the information is properly supplied. Attend morning meetings with production to discuss testing status.
Review and approve the daily logs reported by the QC lab.
Provide technical and hands on leadership to resolve analytical issues, maintain all instruments, and help communicate data. Ensure all instruments are functional and in good working order and meeting compliance requirements.
Serve as a technical resource for customer complaints and requests.
Input, update, and maintain specifications across the databases and systems and work with the Technical Team.
Lead special projects through completion including, but not limited to, validation work.
Oversee quarterly testing and data monitoring.
Evaluate current instrumentation and their performance and make recommendations on potential new technologies and/or replacements.
Note: The duties listed above are not all inclusive and may be subject to periodic updating or revision.
The Ideal Candidate
Desired Background
Bachelor's degree in chemistry, or related field of study and a minimum of 5 years of lab experience.
Knowledge, Skills & Talents
More specifically, we would seek the following attributes and competencies for the position:
Must be able to apply good safety practice, good laboratory practice - GLP, ISO 9001.
Experience in cGMP, GDP and operate to the quality regime, i.e. FSSC 22000/ISO 22002 is strongly preferred.
Has demonstrated experience and competence with all instrumental analysis and wet chemistry techniques such as GC, GC MS, HPLC, TLC, Liquid Chromatography, automated titrations, physical property testing, color measurement, and spectroscopic techniques; as well as be able to teach the techniques, demonstrate good lab practice, do basic troubleshooting, and maintain good records including lab books. A good sense of smell is required for organoleptic testing.
Computer skills are required as the chemists must be able to use databases, spreadsheets, word processing software, LIMS, and computer-controlled instruments.
Must have excellent written and verbal communication skills. Strong organizational skills, decision-making, and record keeping skills are also required. The ability to work in a team environment as well as independently with minimal supervision is necessary with an aptness to provide adequate communication. This individual will be customer facing and may be required to communicate with customers and team members.
Must have flexibility to work any other shifts and be able to work overtime as required.
Is a strong and reliable trainer.
Highly skilled in analytical instrument operation, troubleshooting, and maintenance.
Ability to assist in research and development of methodology for new product analysis implementation.
Pay and Benefits
The pay rate for this position starts at $28.00/hr. Actual pay will be determined based on education, certifications, experience, qualifications, skills and geographic location. This position is eligible to participate in a short-term incentive program.
Vantage offers a comprehensive benefits package to eligible employees, including:
Medical, HSA, dental, vision
FSA (limited purpose, dependent care, and commuter/parking)
Life and AD&D insurance
Accident, hospital indemnity and critical illness insurance
Short- and long-term disability
EAP, identity theft protection
Paid time off, Parental Leave
401(k) with company match
Equal Employment Opportunity
Vantage is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or any other protected category.
About Vantage
Vantage provides natural solutions to our customers' technical performance and marketing needs through a unique combination of chemistry, application expertise and service. Underpinned by our broad portfolio of formulations, ingredients and actives that are built on a backbone of sustainable oils, fats and their derivatives, Vantage targets selected markets and applications including personal care, food, surface treatment, agriculture, pharma, and consumer and industrial performance. Vantage is headquartered in Deerfield, IL., operates in 11 countries worldwide and employs more than 1,000 talented professionals focused on delivering exceptional customer experiences with every interaction.
We are a dynamic people-centered organization where you'll be part of a collaborative global team. Embracing our cultural diversity, we learn from each other to constantly improve, adapt and iterate. We value the voices and talents of our colleagues, empowering them to drive their unique ideas to completion. We're convinced that exceptionally motivated employees produce outstanding results and we celebrate them by fostering a culture of recognition, development, learning, excellence and shared achievement. Most importantly, we know you're going to like it here. For more information visit: vantagegrp.com or LinkedIn/vantage.
Auto-ApplyQuality Technician
Hartland, WI jobs
Job DescriptionQuality Technician - Direct Hire | Superior Skilled Trades
π° Pay Range: $24-$27/hour π Shift: Second Shift - Monday-Friday, 2:00 PM-10:00 PM
Superior Skilled Trades is hiring a Quality Technician for a full-time, direct-hire opportunity in Hartland, WI.
Under the supervision of the Quality Manager, the Quality Technician is responsible for inspecting incoming materials, in-process components, and finished products to ensure compliance with company quality standards and customer specifications. This role supports production by identifying non-conformances, interpreting technical documents, and assisting with quality-related problem-solving.
Key Responsibilities
Interpret blueprints, work orders, engineering specifications, and routing sheets
Troubleshoot blueprint and bill-of-material discrepancies
Recommend improvements to assembly, welding, and production processes
Perform first-piece, in-process, purchased-part, and final inspections
Identify, isolate, and disposition non-conforming products
Use measurement tools such as Virtek Scanner, ROMER Articulating Arm CMM, protractors, height gages, calipers, and micrometers
Test finished products for paint quality, weld quality, fit, appearance, and dimensional accuracy
Route product for rework as necessary
Complete inspection documentation such as reports, return forms, damage logs, and rework orders
Analyze inspection data and assist in resolving production deviations
Communicate quality issues and tolerance deviations to plant supervision
Recommend updates to existing quality or production standards
Create and submit PPAP documentation
Promote and follow all safety policies and procedures
Maintain clean and organized work areas
Safety Equipment Required: Safety glasses, safety shoes, and hearing protection
QualificationsEducation & Experience
High school diploma or GED required
Either:
3 years of related manufacturing experience, OR
5 years of progressively responsible related experience
Equivalent combinations of education and experience will be considered
Additional in-house training provided as needed
Language Skills
Ability to read and interpret blueprints, work orders, and engineering specifications
Ability to write inspection reports and documentation
Strong communication skills with employees and customers
Mathematical Skills
Ability to calculate dimensions, tolerances, proportions, and percentages
Ability to apply basic algebra and geometry
Reasoning Ability
Ability to solve practical problems with limited standardization
Ability to interpret written, oral, diagram, or schedule instructions
Additional Qualifications
Proficiency using precision measurement tools (micrometers, calipers, dial indicators, protractors, hardness testers, tape measures, profile gauges, etc.)
Knowledge of welding, painting, and fit-up processes is beneficial
π§° Apply today to join a precision-driven manufacturing team through Superior Skilled Trades!
Keywords: Quality Technician, Quality Inspector, Manufacturing Quality, CMM, Blueprint Reading, PPAP, Inspection, Hartland WI Jobs, Skilled Trades, Superior Skilled Trades
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Quality Technician - Visual Inspection
Birmingham, AL jobs
Job Description
A Quality - Visual Inspection Technician is a key member of the Quality Team and plays a critical role in ensuring that compounded pharmaceutical products are accurately prepared and without defects. Visual inspection is the first of several post-production activities where filled compounded products are visually evaluated for product defects. This technician is responsible for working with production and quality staff to prioritize batches for visual inspection, completing visual inspection of batches within reasonable timeframes, appropriately classifying observed defects, and performing additional pre-release inspections. While visual inspection is the main emphasis for this position, this position will also participate in other quality related tasks and duties.
Job Activities and Responsibilities: The responsibilities listed below are subject to change.
Post-Production Visual Inspection of Finished Drug Products
Perform visual inspection of unlabeled finished drug products
Classify observed defects into pre-defined categories
Calculates percent defects on inspection results and reconciles components
Proper documentation of visual inspection activities on associated compounding records in accordance with procedures, CGMP, and CGDP
Labeling of Finished Drug Products
Label all products following facility and regulatory requirements
Perform post-labeling inspections
Quality Control Functions and Tasks
Perform environmental and personnel monitoring associated with batch production
Conduct routine environmental monitoring of controlled compounding areas
Record room conditions in appropriate monitoring software
Other routine quality control tasks as determined by the Quality Management
Quality Assurance and Compliance
Adhere to FDA 503B guidelines, cGMP standards, and USP requirements to ensure product safety and quality.
Follow established protocols for documentation, reporting, and record-keeping
Safety and Facility Maintenance
Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation
Participate in routine facility cleaning schedules, ensuring a clean work environment
Report any equipment malfunctions or safety concerns to supervisors
Assist other process functions as required.
Qualifications and Education Requirements
Educational Background: High school diploma or equivalent; licensed as a pharmacy technician with the Alabama State Board of Pharmacy.
Experience: Prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality.
Attention to Detail: Effective organization skills, attention to detail, and the maintenance of precise records.
Physical Requirements: Ability to stand for extended periods, lift moderate weights, and work in a controlled environment; must have 20/20 vision either aided or unaided and complete inspection certification
Must have the ability to complete a two-day off-site training program
Physical Requirements:
Proficient in using a computer and related equipment, including printers and fax machines.
Ability to sit or stand for extended periods.
Effective communication skills via telephone and email.
Able to work in a controlled environment
Capable of lifting up to 40 pounds as needed.
20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.
KEY COMPETENCIES
Regulatory Knowledge: Familiarity with FDA, cGMP, and USP guidelines is a strong asset.
Visual ability to detect defects (as demonstrated through competency assessments)
Collaboration: Works well with cross-functional teams, including quality control, shipping, and pharmacists.
Regulatory Compliance: Strong understanding of 503B regulations and dedication to following all facility protocols.
Benefits:
Health care insurance (medical, dental, vision)
Life Insurance
Supplemental Insurance
PTO
401K matching
Sick leave
Quality Technician 503B
Birmingham, AL jobs
Job Description
The Quality Technician ensures that all compounded products are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications. This position is responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods. This position requires strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position. This position is responsible for working collaboratively with other personnel in the Quality Department to ensure the highest quality product is delivered to the consumer.
Job Activities and Responsibilities:
Collect and send samples of compounded sterile preparations (CSPs) for sterility, potency, and endotoxin testing.
Conduct environmental monitoring (e.g., air and surface sampling) in cleanrooms to ensure compliance with regulatory standards.
Perform visual inspection of finished drug products.
Maintain incubation schedules of environmental monitoring sample plates and document results in associated reports and batch records.
Maintain accurate and thorough records of all testing and inspections.
Ensure all documentation complies with FDA 503B regulations, USP standards, and internal SOPs.
Review batch records and verify that all procedures were followed correctly.
Assist in internal and external audits to ensure compliance with FDA regulations, USP , USP, and other applicable guidelines.
Work closely with the Quality Assurance (QA) team to implement corrective and preventive actions (CAPAs) when non-conformities are identified.
Maintain effective communication and partnership with Operations Management department.
Participate in root cause analysis to find the sources of defects or quality problems.
Ensure that all QC laboratory equipment is properly calibrated and maintained according to the manufacturer's specifications.
Review of draft and executed batch records, release of pharmaceutical products, and QA review and approval of product label proofs.
Participate in continuous improvement initiatives to enhance the quality control processes and overall product quality.
Provide input on QC methods and assist in the development of new testing procedures as needed.
Assist with SOP training, personnel training and competency assessments for handwashing/garbing and training of quality technicians.
Train other staff members on QC procedures and best practices.
Stay current with new regulations, guidelines, and techniques related to quality control in 503B compounding
Oversight of validation projects (i.e. equipment, facility, methods, and process), deviation investigations, and CAPA and Out of Specifications (OOS) investigations.
Ensure all QC activities comply with FDA 503B requirements and other relevant regulatory bodies.
Prepare and review QC sections of regulatory submissions.
Under the direction of supervisor/lead, document, initiate, and investigate quality events for deviations and noncompliance.
Conduct internal audits and gap analysis of processes, systems, and procedures.
Assist with external, regulatory inspections.
Maintain quality records (equipment calibration and maintenance, training, deviation and noncompliance investigations, environmental monitoring, Certificate of Analysis, clean room certification etc.).
Maintain quality standards by approving incoming materials, in-process production, and finished products.
Receive, store, and log in samples for testing analysis.
Participate in investigations into any deviations, out-of-specification results, or product complaints.
Collaborate with QA to resolve issues and prevent recurrence.
Other duties, responsibilities and qualifications may be required and/or assigned as necessary.
Qualifications and Education Requirements
Compounding, cGMP, and/or laboratory experience preferred
High school diploma required and Associates or Bachelor's degree in Health Sciences/Microbiology preferred
Must be able to follow gowning/garbing procedures including wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) as outlined in site SOPs
Strong written communication and interpersonal skills.
Demonstrated ability to work in a demanding, high performance work environment and create a positive, team-oriented culture.
Must be well organized and detail-oriented with proven initiative and self-starter skills.
Must possess problem solving and analytical skills
Demonstrated ability to direct individuals and delegate responsibilities and tasks
Excellent work ethic, including a personal drive to excel independently.
Solid PC skills including Microsoft Office Suite (Word, Excel, Outlook)
20/20 Vision (either aided or unaided) as required by CGMP regulations for visual inspection of finished drug products.
Physical requirements:
Ability to use a computer and computer-related equipment, printer/fax machine
Prolonged periods of sitting and/or standing.
Communicate by telephone and email
Lift to forty (40) pounds at times.
20/20 vision (either aided or unaided)
Benefits:
Health care insurance (medical, dental, vision)
Life Insurance
Supplemental Insurance
PTO
401K matching
Sick leave
Quality Technician
Hartland, WI jobs
Job DescriptionQuality Technician - Direct Hire | Superior Skilled Trades
π
Superior Skilled Trades is hiring a Quality Technician for a direct hire opportunity in Hartland, WI.
Under the supervision of the Quality Manager, the Quality Technician is responsible for inspecting incoming materials, in-process parts, and finished products to ensure compliance with company standards and customer specifications. This position is ideal for candidates with a strong background in manufacturing quality control, blueprint interpretation, and precision measurement.
Key Responsibilities
Read and interpret blueprints, engineering drawings, work orders, and specifications to determine production standards and tolerances.
Perform first-piece, in-process, and final inspections to ensure parts meet quality requirements.
Identify, isolate, and document non-conforming products and assist with root-cause analysis.
Operate and utilize precision measurement tools such as calipers, micrometers, height gauges, protractors, Virtek Scanner, and ROMER Arm CMM.
Test finished products for paint quality, weld quality, fit, dimensions, and overall appearance.
Complete all required documentation including inspection reports, rework orders, and PPAP submissions.
Work collaboratively with production to resolve quality concerns and improve processes.
Maintain cleanliness, organization, and adherence to safety policies within the department.
Qualifications
High school diploma or GED required.
3+ years of quality or inspection experience in a manufacturing environment (or 5+ years of progressively responsible related experience).
Strong ability to read blueprints, routings, and specifications.
Working knowledge of welding, painting, and fabrication fit-up preferred.
Proficient in the use of precision measuring instruments.
Ability to calculate dimensions, tolerances, and proportions using basic algebra and geometry.
Excellent attention to detail, communication, and problem-solving skills.
Physical Requirements
Ability to stand, walk, and use hands for extended periods.
Occasionally lift and move up to 50 lbs.
Regular use of precision tools and inspection equipment requiring close and color vision.
Comfortable in a manufacturing environment with moderate to loud noise levels.
Work Environment
Factory setting with exposure to moving mechanical parts and occasional airborne particles.
PPE provided and required (safety shoes, glasses, hearing protection).
Why Apply?
Direct hire through Superior Skilled Trades - full benefits from day one.
Competitive pay and consistent schedule.
Join a collaborative team focused on quality, safety, and craftsmanship.
Long-term opportunity with career growth potential.
π§° Apply today to join a precision-driven manufacturing team through Superior Skilled Trades!
Keywords: Quality Technician, Quality Inspector, Manufacturing Quality, CMM, Blueprint Reading, PPAP, Inspection, Hartland WI Jobs, Skilled Trades, Superior Skilled Trades
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Quality Technician
Hartland, WI jobs
Job DescriptionQuality Technician - Direct Hire | Superior Skilled Trades
π
Superior Skilled Trades is hiring a Quality Technician for a direct hire opportunity in Hartland, WI.
Under the supervision of the Quality Manager, the Quality Technician is responsible for inspecting incoming materials, in-process parts, and finished products to ensure compliance with company standards and customer specifications. This position is ideal for candidates with a strong background in manufacturing quality control, blueprint interpretation, and precision measurement.
Key Responsibilities
Read and interpret blueprints, engineering drawings, work orders, and specifications to determine production standards and tolerances.
Perform first-piece, in-process, and final inspections to ensure parts meet quality requirements.
Identify, isolate, and document non-conforming products and assist with root-cause analysis.
Operate and utilize precision measurement tools such as calipers, micrometers, height gauges, protractors, Virtek Scanner, and ROMER Arm CMM.
Test finished products for paint quality, weld quality, fit, dimensions, and overall appearance.
Complete all required documentation including inspection reports, rework orders, and PPAP submissions.
Work collaboratively with production to resolve quality concerns and improve processes.
Maintain cleanliness, organization, and adherence to safety policies within the department.
Qualifications
High school diploma or GED required.
3+ years of quality or inspection experience in a manufacturing environment (or 5+ years of progressively responsible related experience).
Strong ability to read blueprints, routings, and specifications.
Working knowledge of welding, painting, and fabrication fit-up preferred.
Proficient in the use of precision measuring instruments.
Ability to calculate dimensions, tolerances, and proportions using basic algebra and geometry.
Excellent attention to detail, communication, and problem-solving skills.
Physical Requirements
Ability to stand, walk, and use hands for extended periods.
Occasionally lift and move up to 50 lbs.
Regular use of precision tools and inspection equipment requiring close and color vision.
Comfortable in a manufacturing environment with moderate to loud noise levels.
Work Environment
Factory setting with exposure to moving mechanical parts and occasional airborne particles.
PPE provided and required (safety shoes, glasses, hearing protection).
Why Apply?
Direct hire through Superior Skilled Trades - full benefits from day one.
Competitive pay and consistent schedule.
Join a collaborative team focused on quality, safety, and craftsmanship.
Long-term opportunity with career growth potential.
π§° Apply today to join a precision-driven manufacturing team through Superior Skilled Trades!
Keywords: Quality Technician, Quality Inspector, Manufacturing Quality, CMM, Blueprint Reading, PPAP, Inspection, Hartland WI Jobs, Skilled Trades, Superior Skilled Trades
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Quality Technician
Hartland, WI jobs
Quality Technician - Direct Hire | Superior Skilled Trades
π
Superior Skilled Trades is hiring a Quality Technician for a direct hire opportunity in Hartland, WI.
Under the supervision of the Quality Manager, the Quality Technician is responsible for inspecting incoming materials, in-process parts, and finished products to ensure compliance with company standards and customer specifications. This position is ideal for candidates with a strong background in manufacturing quality control, blueprint interpretation, and precision measurement.
Key Responsibilities
Read and interpret blueprints, engineering drawings, work orders, and specifications to determine production standards and tolerances.
Perform first-piece, in-process, and final inspections to ensure parts meet quality requirements.
Identify, isolate, and document non-conforming products and assist with root-cause analysis.
Operate and utilize precision measurement tools such as calipers, micrometers, height gauges, protractors, Virtek Scanner, and ROMER Arm CMM.
Test finished products for paint quality, weld quality, fit, dimensions, and overall appearance.
Complete all required documentation including inspection reports, rework orders, and PPAP submissions.
Work collaboratively with production to resolve quality concerns and improve processes.
Maintain cleanliness, organization, and adherence to safety policies within the department.
Qualifications
High school diploma or GED required.
3+ years of quality or inspection experience in a manufacturing environment (or 5+ years of progressively responsible related experience).
Strong ability to read blueprints, routings, and specifications.
Working knowledge of welding, painting, and fabrication fit-up preferred.
Proficient in the use of precision measuring instruments.
Ability to calculate dimensions, tolerances, and proportions using basic algebra and geometry.
Excellent attention to detail, communication, and problem-solving skills.
Physical Requirements
Ability to stand, walk, and use hands for extended periods.
Occasionally lift and move up to 50 lbs.
Regular use of precision tools and inspection equipment requiring close and color vision.
Comfortable in a manufacturing environment with moderate to loud noise levels.
Work Environment
Factory setting with exposure to moving mechanical parts and occasional airborne particles.
PPE provided and required (safety shoes, glasses, hearing protection).
Why Apply?
Direct hire through Superior Skilled Trades - full benefits from day one.
Competitive pay and consistent schedule.
Join a collaborative team focused on quality, safety, and craftsmanship.
Long-term opportunity with career growth potential.
π§° Apply today to join a precision-driven manufacturing team through Superior Skilled Trades!
Keywords: Quality Technician, Quality Inspector, Manufacturing Quality, CMM, Blueprint Reading, PPAP, Inspection, Hartland WI Jobs, Skilled Trades, Superior Skilled Trades
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Auto-ApplyQuality Technician
Easton, MD jobs
Job Details Experienced Liquid and Topicals Division MD - Easton, MD Undisclosed N/A Full Time High School $16.00 - $18.00 Hourly None Any QA - Quality ControlDescription Now Hiring: Experienced Quality Technician - Day Shift
π Schedule: Monday - Thursday | 4 x 10-hour shifts (6:30 AM - 5:30 PM)
β‘ Potential Mandatory Overtime on Fridays
π¨ βοΈ Industry: Pharmaceutical, OTC, Dietary Supplements, Animal Health, & Medical Devices
Aphena Pharma Solutions is looking for an Experienced Quality Technician to join our team! We are a dynamic pharma solutions provider specializing in contract packaging, repackaging, and manufacturing. If you have a keen eye for detail and a passion for quality, we want you on our team!
Why Join Aphena? - Our Benefits
β Employee Medical Premiums: 75% paid by Aphena
β Medical Deductible: Partially covered by the company
β Company-Paid Short-Term Disability & Life Insurance
β 401(k) with Company Match
β PTO Accrual after 90 Days
β Paid Holidays & More!
What You'll Be Doing - Key Responsibilities
πΉ Inspect incoming components, in-process products, and finished products based on specifications
πΉ Review documentation before production starts and perform First Piece Approval (FPA)
πΉ Record and maintain data following Good Documentation Practices (GMP)
πΉ Prepare inspection sheets & forms using Microsoft Word and Excel
πΉ Troubleshoot quality concerns on the production floor
πΉ Review & verify accuracy of all paperwork, including Device/Drug History Records (DHR)
πΉ Ensure calibration of all inspection/test equipment and maintain accurate records
πΉ Investigate and gather data for customer complaints
πΉ Assist in process validations and maintain compliance with ISO & FDA GMP regulations
πΉ Perform data entry and retrieval using Aphena's computer system
πΉ Support CAPA processes (Corrective & Preventive Action Plans)
πΉ Document and resolve non-conforming materials and process discrepancies
πΉ Generate controlled labels and handle approvals/documentation
πΉ Maintain a clean and organized work area
What You Need - Required Skills & Experience
β PC proficient - Strong knowledge of Microsoft Word & Excel
β GMP & ISO Knowledge - Understanding of FDA Good Manufacturing Practices & ISO standards
β Strong organizational skills - Ability to prioritize assignments & manage multiple projects
β Excellent communication skills - Ability to interact with vendors, customers, and all levels within the organization
β Detail-oriented & analytical - Strong problem-solving and troubleshooting abilities
β Ability to read & interpret drawings, templates, and technical documentation
β Experience in Quality Control - Previous work with pharmaceuticals or medical devices preferred
Preferred Skills:
β Knowledge of Statistical Process Control (SPC)
β Ability to flowchart and graph data
What We're Looking For - Personal Attributes
β Dependable, energetic, and self-motivated
β Works well under pressure and with minimal supervision
β Trustworthy and detail-oriented
β Flexible and able to prioritize tasks effectively
Physical Requirements
π Must be able to lift and move materials up to 50 lbs
π Will be exposed to dust, perfumes, and chemicals
π Work includes climbing, walking, stooping, kneeling, crouching, reaching, standing, pushing, pulling, lifting, grasping, twisting, and sitting
π Good visual awareness required
Education & Experience
π High school diploma required (advanced coursework preferred)
π Previous experience with GMP regulations in pharmaceuticals or medical devices
π» Proficiency in Microsoft Word, Excel, and the Internet
π§© Strong problem-solving skills for complex, multi-layered issues
Ready to Make an Impact? Apply Today!
Join Aphena Pharma Solutions and be part of a team committed to quality, safety, and excellence in pharmaceutical manufacturing! π
Quality Technician III/IV
Lansing, MI jobs
Quality Technician (Production) III / IV Who we are⦠We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive.
We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living. Who you areβ¦ You love details and precision. You find standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe you are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery. How you make an impactβ¦ You'll provide instrumental support within the quality team and throughout the company to ensure timely product and compliance support. Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to our partners and patients. Our science and risk-based compliant quality culture is innovative and partner oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients. What you will achieveβ¦
Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
Support internal and external audits; support validation of test methods, monitoring processes, and equipment.
Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
Lead and participate in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap.
Lead or support teams through out of tolerance, nonconformances, complaints, and CAPA investigations.
Lead or support teams through change control that support continuous improvement and other needs.
Lead or support Quality Assurance (QA) with completing quality checks and approvals on production records.
What you need to succeedβ¦
Associates or Bachelor degree or equivalent in science or other related field.
5+ years related experience, with a solid understanding of regulatory compliance related to operations and quality procedures.
Experience in quality assurance or quality control roles within a manufacturing or industrial environment.
Knowledge and experience in eQMS, Inspection, Measuring and Test Equipment (IMTE) management systems, statistical process control (SPC), and root cause analysis methodologies (Six Sigma RCA).
Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
Understands how to integrate into a new team/organization - appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
Understands their own communication and learning styles, can assess others' styles, and is able to find the right path to connect the two.
Great to haveβ¦
Certification in quality management or related field (e.g., Certified Quality Technician/Engineer, Six Sigma).
Experience in a facility with radiation regulatory requirements and or quality assurance experience with pharmaceuticals or medical devices.
Experience with Minitab, JMP or other analytical tools.
Experience in audits (internal, NRC, FDA, etc.).
Knowledge of ISO 13485, 21 CFR 820, 21 CFR 210/211, and Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience.
Work Environment
The company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts.
This position will have regular working hours during M - F with an expectation of adjusting to operational commitments as needed.
Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
While performing the duties of this job, the employee is occasionally required to:
use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; walk throughout all locations of the company; talk and hear; wear safety glasses, googles, gloves, lab coat and/or Tyvek suit.
The employee must occasionally lift or move office products and supplies, up to 25 pounds. This position may stand and sit for prolonged periods.
Please provide a cover letter specifically describing the nature of your interest & expertise.
Quality Technician II
Lansing, MI jobs
Summary/objective The Quality Technician II plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products. The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.
Quality Technician III
Lansing, MI jobs
Summary/objective
The Quality Technician III plays a pivotal role in ensuring the effective, efficient, compliant, and proactive support of new product launches and the continuous quality of existing products.
The Quality Technician loves details and precision. This role finds standardized work in which deviation could cause an undesirable outcome to be invigorating. Analyzing processes and results to control variations and discussing when improvements would best be introduced is a desirable pastime. Words that describe the Quality Tech are dedicated, efficient, and someone who contributes to making the workday fly by with engaging conversation and team comradery.
Quality Technician II (Production)
Lansing, MI jobs
Essential Functions
Monitor and maintain the state of inventory, quality, equipment, maintenance, calibration and facilities and ensure they comply with QS and cGMP requirements.
Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
Support internal and external audits.
Support validation of test methods, monitoring processes, and equipment.
Support production teams in product/material hold, release, disposition, and traceability assessments, and implement improvements to reduce recurring deviations that lead to rework or scrap.
Support new product introduction (NPI) quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
Collaborate with cross-functional teams to support and solve production and quality challenges.
Collect, monitor, analyze and communicate data to provide insight on quality metrics set by the management team.
Quality Tech II
Saint Louis, MO jobs
**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
** Summary**
Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods.
**Job Description**
**ESSENTIAL FUNCTIONS:**
+ Follow good documentation practices for the accurate and timely documentation of all activities.
+ Perform wet chemistry and instrumentation testing.
+ Follow site HSE Policies.
+ Assist with establishing and maintaining safe work standards in the lab.
+ Peer review all levels of work.
+ Conducts lab investigations.
**DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:**
+ LIMS entry of data
+ Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter
+ Maintain instrument readiness
**MINIMUM REQUIREMENTS** **:**
_Education:_
High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred.
_Experience:_
Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred.
_Preferred Skills/Qualifications:_
+ Working knowledge of wet chemistry required
+ Working knowledge of instrumentation (GC/LC, UV, AA).
+ Experience in a cGMP environment is preferred.
+ Basic computer skills and familiarity with Microsoft Office Suite.
+ Substantial acquaintance with and understanding of application of basic principles, theories and concept.
+ Use and/or Basic knowledge of industry practices and standards.
+ Chromatography (GC/LC) and Spectroscopy experience a plus.
**COMPETENCIES:**
Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management
**ORGANIZATIONAL RELATIONSHIP/SCOPE:**
Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters.
**WORKING CONDITIONS:**
+ 80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds.
+ 20% Office environment.
+ Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab
**DISCLAIMER:**
_The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require_
**EEO Statement:**
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Quality Tech II
Saint Louis, MO jobs
Why Us?
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Summary
Depending on the laboratory area, will perform analysis on Raw Materials, Intermediates, In-Process, Finished Product, or Stability samples using established analytical methods.
Job Description
ESSENTIAL FUNCTIONS:
Follow good documentation practices for the accurate and timely documentation of all activities.
Perform wet chemistry and instrumentation testing.
Follow site HSE Policies.
Assist with establishing and maintaining safe work standards in the lab.
Peer review all levels of work.
Conducts lab investigations.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
LIMS entry of data
Use of analytical balances, HPLC, GC, KF Titrator, UV, pH Meter
Maintain instrument readiness
MINIMUM REQUIREMENTS:
Education:
High School Diploma required, associate degree in a science related field or equivalent combined education, experience, and competencies preferred.
Experience:
Experience in a cGMP environment is preferred. Working knowledge of instrumentation preferred.
Preferred Skills/Qualifications:
Working knowledge of wet chemistry required
Working knowledge of instrumentation (GC/LC, UV, AA).
Experience in a cGMP environment is preferred.
Basic computer skills and familiarity with Microsoft Office Suite.
Substantial acquaintance with and understanding of application of basic principles, theories and concept.
Use and/or Basic knowledge of industry practices and standards.
Chromatography (GC/LC) and Spectroscopy experience a plus.
COMPETENCIES:
Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management
ORGANIZATIONAL RELATIONSHIP/SCOPE:
Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA. Infrequent customer contacts on routine matters.
WORKING CONDITIONS:
80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds.
20% Office environment.
Required to work 8-12 hour shifts, the potential for night, weekend, and holiday work depending on the lab
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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