QA/QC Manager
Quality Assurance Auditor Job In Ashburn, VA
Datacenter People is a specialised recruitment company working with the leading data center commissioning and quality services firms in the world.
Our client serves as an owner's representative, specialising in Data Center commissioning and QA/QC services.
The Role
Actively supports the Company's commitment to safety and its core values.
Performs quality inspections in accordance with program quality control documentation. Participate and guide project quality control from kick-off until hand-off.
Provides oversight of the implementation of the QA/QC management system at site.
Coordinates the quality inspections with the site sub-contractors and vendors.
Coordinates with the customers representative on all quality matters.
Provides oversight in the distribution of relevant QA/QC documentation to site subcontractors while reviewing that completed documentation is stored appropriately upon completion.
Verifies that the quality related site activities are in accordance with the design documents and program standards.
Participates in the internal and external site audits.
Coordinates all the quality site inspections through the Contractor QC team.
Ensures all quality control documentation is compiled and competed for as-built hand over through the Contractor QC team.
Provide review and reporting of all non-conformance reports and undertake remedial action. Monitors the implementation of the approved site QC Plan.
Completes and coordinates the approval of the sites QC technical submittals to the customer.
Coordinates with the Client and Contractor QA/QC team on all quality issues.
Coordinate and chair the QA/QC site weekly meetings with the Contractor QC personnel.
Assures all technical documents relative to site quality control are of current status.
The Experience Profile
Has data center commissioning/QA experience.
Has a history and experience driving improved Quality at scale.
Is able to work seamlessly across functional and department lines.
Has experience with standard data center equipment to include: electrical distribution equipment from switchgear to panelboards, VFDs, low voltage power and moulded case circuit breakers, overhead IT busway, Diesel Generators, DX units, air handlers, water treatment equipment, BMS modules, and hot aisle containment accessories.
Is able to travel domestically and internationally as needed.
We regret that due to the high volume of applications we are unable to acknowledge each one. Please bear in mind that if you are selected for interview we will contact you within the next seven days.
Auditor, Compliance Services Audit
Quality Assurance Auditor Job In Richmond, VA
8901 - Corp Office West Crk - 12800 Tuckahoe Creek Parkway, Richmond, Virginia, 23238CarMax, the way your career should be!
Help assure honesty and transparency in every interaction
CarMax has a long-standing commitment to compliance and conducting business with integrity. As such, CarMax Compliance Services Audit performs a variety of testing/audits to assess operational compliance with applicable state and federal laws, regulations, guidelines, and internal policies/procedures. As an Auditor, you will work with a variety of associates and leaders throughout the organization at CarMax Auto Finance (CAF) and CarMax to assess the Companys compliance.
Help assure honesty and transparency in every interaction
CarMax has a long-standing commitment to compliance and conducting business with integrity. As such, CarMax Compliance Services Audit performs a variety of testing/audits to assess operational compliance with applicable state and federal laws, regulations, guidelines, and internal policies/procedures. As an Auditor, you will work with a variety of associates and leaders throughout the organization at CarMax Auto Finance (CAF) and CarMax to assess the Companys compliance.
Work Location and Arrangement: This role will be based out of the Kennesaw, GA CAF location and have a Hybrid work arrangement
Work Authorization: Applicants must be currently authorized to work in the United States on a full-time basis.
What youll do Essential Responsibilities
Assist in the planning and execution of company operational regulatory compliance audits.
Perform testing of company processes to ensure compliance with laws and regulations in a complex multi-state environment.
Assist in the development of value-added services (i.e. process improvements and best practice policies) for different operational areas, with guidance from other Compliance Associates and Mangers.
Assist in gathering and testing documentation required for compliance audits, services provider compliance audits, CarMax product reviews, store audits, external examinations, conduit banks reviews, and securitization parties all within the scope of operational regulatory compliance.
Perform and ensure execution of other administrative tasks/projects as assigned.
Improve customer experience with every interaction
Integrity is a foundational CarMax value that CarMax Compliance Services Audit is uniquely positioned to champion by assuring honesty and transparency in every interaction. With your background, you will help us continue to build a compliance audit function that uses a strong analytical mindset, data analysis techniques, curiosity, accountability, teamwork, and strong communication skills to ensure our organization offers an iconic customer experience in every transaction.
Qualifications and requirements
Bachelors degree in accounting, finance, or related field and 1-2 years of audit, auto finance operations, or compliance experience or 5+ years relevant formal compliance or audit experience in lieu of a degree.
CPA, CIA, or CISA are a plus.
Strong background in internal controls and compliance.
Excellent business writing and verbal communication skills.
Ability to interact effectively with various levels of management in business units, work on team based projects in addition to working independently.
Excellent time management and self-management skills in addition to strong attention to detail are required for this role.
About CarMax
CarMax disrupted the auto industry by delivering the honest, transparent and high-integrity experience customers want and deserve. This innovative thinkingaround the way cars are bought and soldhas helped us become the nations largest retailer of used cars, with over 200 locations nationwide.
Ouramazing team of more than 25,000 associates work together to deliver iconic customer experiences.Along the way,we help every associate grow their career and achieve their best, at work and in their community. We are recognized for our commitment to training and diversity and areone of the FORTUNE 100 Best Companies to Work For.
CarMax is an equal opportunity employer, and all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Upon an applicant's request, CarMax will consider reasonable accommodation to complete the CarMax Job Application.
RequiredPreferredJob Industries
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Quality Assurance Manager
Quality Assurance Auditor Job In Fairfax, VA
WITH CONSUMER CONNECTION***
Our client is seeking a Quality and Food Safety Manager for our food manufacturing client.
Provides leadership to the company's Quality Food Safety department through coaching and development of front-line associates, driving a culture of safety, inclusion, engagement and accountability.
Promotes a culture of Food Safety among all bakery associates through education and policy enforcement along with fellow department leaders.
Ensures that our customer's receive the highest quality product in a food safe environment.
Provides oversight of Quality and Food Safety programs, and evaluates for compliance through regular audits, inspections and risk assessments, ensuring that Corrective Actions are performed for any non-conformance.
Ensures proper document control for all documentation within the food manufacturing facility.
Leads all third-party audits .Example is SQF (Safe Quality Foods)
Drives continuous improvement by ensuring that LEAN tools and 5S are practiced.
Participates in and supports R&D efforts, through ingredient analysis and approval, and ensures that all regulatory guidelines are met.
Qualifications
Bachelor's degree in Food Science or related scientific major preferred. A combination of education, training and experience that results in demonstrated competency to perform the work may be substituted.
GFSI (SQF, BRC, FSSC 22000, IFS, etc), PCQI, Food Defense and HACCP certifications strongly preferred.
5-7 years of experience leading Quality/Food Safety/Sanitation teams in a food production environment.
Leadership skills with a focus on associate development and accountability.
Excellent communication and interpersonal skills with the ability to work within cross-functional teams.
Computer proficiency including MS Office products.
Experience with 5S and LEAN tools highly preferred.
Bilingual - Spanish and English highly preferred.
Food Quality Assurance Specialist
Quality Assurance Auditor Job In Sterling, VA
Food Quality Assurance / Supply Chain Specialist
Department: Supply Chain
Industry: Food Manufacturing
Status: Full Time - Onsite (Monday - Friday from 8am to 4:30pm)
Jones Networking is recruiting for a Food Quality Assurance Specialist to join the Supply Chain Department of a premium food manufacturing company in Sterling, VA. Our client offers the opportunity for a long term, rewarding career with excellent benefits and career growth potential. Benefits include medical, dental and vision insurance, 401(k) + 2% company match, life and disability insurance, paid vacation & holidays, bonus opportunities, employee assistance program, corporate discounts and much more!
Food Quality Assurance / Supply Chain Specialist Position Summary:
-Maintain supply chain procedures for the department within the corporate office.
-Communicate with suppliers regarding initial approval, annual renewal process, as well as item-related documentation requests and follow ups.
-Capture and organize food safety and ingredient documentation (electronically) from suppliers.
-Work with the corporate Food QA Team and Supply QA Team to assess all suppliers.
-Partner with the Procurement Team to ensure material risk assessment specifications are reviewed and agreed upon by the supplier.
-Update supply chain QA databases, documenting the raw materials, food/non-food
products, processes and regulatory requirements.
-Create item information on Genesis R&D, ERPs, and supplier management software.
-Assist sites with audits regarding supply chain programs.
-Work with stakeholders and suppliers regarding export related documentation.
-Partner with cross-functional teams regarding the on-boarding of new commodities and suppliers.
-Effectively communicate scientific and technical information to both technical and non-technical personnel.
Qualifications Summary:
-Associate Degree and/or Bachelor's Degree in Biology, Microbiology, Food Science, Biochemistry or similar field required.
-Prior experience within the food industry with knowledge of GMPs,
Food Safety, Quality Systems, Quality Assurance and Quality Control.
-Working knowledge of compliance expectations for the manufacture of food products. (FDA, USDA & Food Code regulations)
-Strong analytical skills with excellent attention to detail.
-Ability to successfully execute complex tasks simultaneously.
Please visit jonesnet.com for a full list of career opportunities presented by Jones Networking!
Remote Healthcare Compliance Auditor
Remote Quality Assurance Auditor Job
A healthcare facility is actively seeking a Remote Healthcare Compliance Auditor to join their team.
The following qualifications are preferred:
At least two (2) years of healthcare auditing experience.
Certified Professional Coder (CPC) or equivalent certification (will consider a commitment to complete certification within the first year of employment)
The Remote Healthcare Compliance Auditor will play a vital role within this care organization. As the Compliance Auditor, you will analyze audit results to determine the root cause of errors and recommend process improvements. The Auditor will also manage compliance program incident logs and review error trends to identify training opportunities.
Take this exciting opportunity to join a remarkable team as a Remote Healthcare Compliance Auditor. This role offers a competitive salary and generous benefits, with the greatest benefit of being remote. Submit your resume and connect with a recruiter to learn more about this opportunity.
Electrical Quality Specialist
Quality Assurance Auditor Job In Richmond, VA
Type: Full-Time (Direct Hire)
Reports to: Quality Manager
Salary Range: $85,000 to $110,000
Overview: In this role, you will have the opportunity to support the deployment of the quality strategy for a local organizational unit, including quality culture, systems, tools, and competent teams with the aim to achieve and exceed customer expectations, while ensuring sustainable operations. Each day, you will assist the organization in achieving the right mix of prevention, continuous improvement, robust root cause analysis, quick response, and sustainable solutions to problems. You will also showcase your expertise by collaborating with local functions that impact the quality results to reach the targets for the organizational unit and aim for world-class performance.
Responsibilities:
Supporting specific communication relevant to quality management in your area of responsibility.
Assisting in continuously identifying and addressing risks and opportunities related to quality management in the local organization.
Using quality data analytics from the organization to identify risks, failures, and non-conformances.
Facilitating resolution of customer cases by following a robust root cause analysis and implementing preventive and corrective actions.
Qualifications:
Bachelor's degree in Electrical Engineering (or a related field).
Minimum of 8 years of experience in a manufacturing or quality control environment.
Hands-on experience with transformers, PDUs, STSs, and UPS products. Proficiency in testing, troubleshooting, evaluating, and servicing electrical distribution and control systems.
Ability to read and interpret schematics of electrical equipment and printed circuit board assemblies (PCBAs); skilled in using electrical test equipment such as power supplies, multimeters, oscilloscopes, and power analyzers.
Familiarity with Lean, Six Sigma, and other process improvement methodologies is highly desirable.
Knowledge of industry standards such as UL1561, NEMA ST-20, IEEE C57.12.01, IEEE C57.12.91, DOE 2016, UL891, and CSA C22.2 preferred
Able to travel up to 15% domestic
Lead Principal Auditor - Credit Risk
Remote Quality Assurance Auditor Job
Job Title Lead Principal Auditor - Credit Risk
Corporate Title Vice President
The Group Audit (GA) function comprises c. 700 staff who take a proactive, risk based and independent approach to assist the Bank's business and infrastructure functions to identify key control weaknesses. GA prides itself in ensuring the highest standard in professional delivery. Being The Bank's ‘third line of defense' GA have a high internal profile, acting as an independent and forward-looking challenger and adviser to Senior Management. We are strongly relied upon by the Regulators. We are a diverse and inclusive global division where culture is at the core of our team dynamic; GA is inextricably linked to promoting strong corporate and ethical governance, a philosophy that it is the responsibility of each, and every Professional employed within The Bank; GA is about trust, excellence, people, and performance.
What We Offer You
A diverse and inclusive environment that embraces change, innovation, and collaboration
A hybrid working model, allowing for in-office / work from home flexibility, generous vacation, personal and volunteer days
Employee Resource Groups support an inclusive workplace for everyone and promote community engagement
Competitive compensation packages including health and wellbeing benefits, retirement savings plans, parental leave, and family building benefits
Educational resources, matching gift and volunteer programs
What You'll Do
The Lead Principal Auditor typically leads highly complex audits of a specific business/functional area/region, and evaluates the adequacy and effectiveness of internal controls relating to risks within those business areas
Support the PAM in managing a portfolio of audits and will actively contribute to global audit initiatives
In addition to audit related tasks, the Lead Principal Auditor can take over responsibility from the PAM to direct and coach/develop auditors but will not directly have team management responsibility
Proactively develop and maintain professional consultative working relationships with the internal Audit function, clients and respective support areas and will use a range of approaches to collect relevant information to assess key risks, resolve major issues or carry out tasks across a portfolio
Represent the division at committees and forums, both internally and externally. The Lead Principal Auditor can lead discussions with regulators
Facilitate the tracking of and validating closure of internal audit issues and regulatory findings. Perform business monitoring and risk assessments enabling the prioritization of audit delivery
How You'll Lead
Experience in coaching and developing junior staff
Act as the escalation point between your team and the Credit Risk Management stakeholders during audit delivery or finding validation
Ability to have challenging conversations with members of your audit team and identifying any skill gaps
Skills You'll Need
Subject Matter Expertise (SME) within Credit Risk required (SME within Market and Model Risk is a plus); experience in managing audit staff to deliver timely audit completion
Someone with an inquisitive mindset who isn't afraid to ask questions until the process is understood
Ability and willingness to work in a high-pressure environment and deliver under tight deadlines. Ability to project manage your time and that of others to ensure audit completion
Team working capabilities and the ability to build strong business and team relationships
Undergraduate or equivalent degree required; advanced degrees and relevant professional certifications preferred but not required
Skills That Will Help You Excel
Experience with People Managing skills
Expectations
It is the Bank's expectation that employees hired into this role will work in the New York City office in accordance with the Bank's hybrid working model.
The Bank provides reasonable accommodations to candidates and employees with a substantiated need based on disability and/or religion.
The salary range for this position in New York City is $125,000 to $203,000. Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, work location and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.
Quality Assurance Manager
Quality Assurance Auditor Job In Salem, VA
We Create Products and Brands That People Trust to Clean, Sanitize, and Protect Their Homes and Pools
When you join KIK Consumer Products, you're joining a team that cares about the work we do and also about each other. We bring exceptional brands and products to consumers that help them protect the health and wellness of their families and the cleanliness of their homes and pools. We are committed to building a culture of performance driven by accountability, collaboration, and agility that enables timely fact-based decision-making and exceptional execution with unwavering ethics. As one of North America's largest independent manufacturers of consumer products, KIK helps a large portfolio of brands and retailers bring their products to life.
Your Role at KIK
As the Quality Assurance Manager, you will report to the Plant Manager. In this role, you are responsible for overseeing the development, implementation, and maintenance of quality assurance systems and processes to ensure that products or services meet established standards and customer expectations. This role involves leading a team of QA professionals, collaborating with cross-functional teams, and driving continuous improvement initiatives.
What You'll Be Doing
Generate quality metric reports and graphs for the General Manager.
Work with Processing Department to standardize the chemical batching process
Familiar with quality systems and batching processes
Manage, direct, and train Quality Laboratory Technician. Train on the use of KIK Quality Systems and all laboratory equipment. Provide supervision, coaching, and counseling.
Train Tank Farm personnel on how to titrate samples for Sodium Hypochlorite and Caustic levels
Conduct quality training for all plant personnel. Document all procedures.
Lead on all external and regulatory quality audits
Ability to take a formula card and develop a batching procedure with the Processing Department
Work with vendors to resolve quality issues with raw materials or ingredients
Review and approve all packaging changes
Maintain the CoLOS database for bottle and case printing.
Ability to make suggestions and informed decisions quickly.
Ensure packaging operations adhere to all regulatory GMP and customer requirements for finished goods quality.
Maintain a working knowledge of government and industry quality assurance codes and standards.
Ensure all incoming testing of packaging and chemicals are completed according to GMP and customer requirements.
Provide technical assistance to other departments, suppliers and customers as needed.
Audit batch records to ensure compliance with applicable regulations.
Investigate non-conformance batches and finished products.
Interact with customers as required to support new product startups and development.
Develop ways to improve component, on-line and finished product inspection methods to improve quality.
Maintain formal quality improvement program, including supporting methodology, tools and training materials.
Direct core processes and/or systems reviews. Assess critical-to-quality gaps, determine root cause, build business cases for improvement opportunities, and implement control procedures to measure and monitor results.
What You'll Bring
BS in Chemistry preferred
Minimum 3 years of Quality experience in manufacturing or related field a plus
Excellent organizational skills with the ability to prioritize workload
Proficient computer skills, especially in Microsoft Office specializing in advanced Excel
Ability to perform chemical concentration calculations
Ability to work in a fast-paced, time-sensitive environment
Strong communication skills at all levels
What You Will Get
KIK offers a competitive salary and comprehensive benefits including health, wellness, dental, vision, life, and disability insurance. You can plan for your future with KIK's retirement savings options including employer match. KIK also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.
About KIK
We create the products and brands that people trust to clean, sanitize, and protect their homes, pools, and cars. We are one of North America's largest independent consumer product manufacturers with 16 North American manufacturing facilities. We also operate globally in Canada, Europe, and Australia. We are known for our portfolio of notable brands including Spic and Span and Comet cleaning products, Clorox Pool&Spa™ (under license), BioGuard , and Natural Chemistry pool chemicals. We are also the #1 producer in North America of store-brand (“private label”) bleach and a leading private-label provider of laundry detergent and additives, dishwashing products, general-purpose cleaning, and other home care products.
Our global team of over 2,300 employees drives our capabilities in product development, product formulation, strategic sourcing, manufacturing, packaging design, brand marketing, project management, quality assurance, compliance, distribution, and logistics.
Our organization is constantly evolving and is driven by a set of “One KIK” values - a dedication to following through on commitments in a customer-focused, profit-motivated way; while never compromising on safety, ethics, or integrity.
KIK is an Equal Employment Opportunity / Affirmative Action employer. KIK does not discriminate against qualified applicants or employees based on race, color, age, religion, sex, pregnancy, national origin, ancestry, age, physical or mental disability, veteran status, status in uniformed services, sexual orientation, gender identity, gender expression, marital status, genetic information or any other status protected by law.
KIK is also committed to providing reasonable accommodations for applicants and employees with protected disabilities to the extent required by applicable laws. If you require a reasonable accommodation to participate in the job application, or interview process, or to perform the essential functions of the job, please contact Human Resources immediately.
Privacy Policy: ************************************************
QA Test Manager
Remote Quality Assurance Auditor Job
Apex Systems is looking for a QA Test Manager to join one of our fortune 500 clients. Please see details below and apply if interested.
Duration: 24 months
Rate: $60-68hr on w2 dependent upon experience
We are unable to work corp-to-corp or provide sponsorship for this role. Candidates must be able to work on Apex Systems W2 without sponsorship now or in the future.
We are unable to accomodate fully remote requests. Candidates must be able to go into the office 3 days a week in Richmond, VA | Charlotte, NC
Position Summary
Test Manager to coordinate the functional testing of multiple applications. Testing will include functional, regression and End-to-End. Work to plan and implement the testing of project in a release.
Required Skills
Experience in coordinating functional, regression and End-to-End testing.
Experience in reporting testing status and progress to LOB and technology teams.
Experience in defect management and coordinate with the project team.
Knowledge of ALM and/or JIRA
Knowledge of SDLC : Waterfall, Agile methodologies
Ability to work in fast paced and changing environment
Ability to communicate with LOB and technology teams
Ability to coordinate with multiple teams in diverse locations
Knowledge of RTP or similar financial transactions protocols
Desired Skills
Knowledge of Jira Tool
Knowledge of financial systems
Work well with LOB and technology team
Quality Assurance Operations Manager
Remote Quality Assurance Auditor Job
*W2 Only
*Remote (Will work EST hours)
*12 Month Contract
Our client is seeking a Manager of Quality Assurance Operations to join their team. This role will support all GMP aspects of drug product (DP) manufacturing, CMC, and alliance management. The Manager will collaborate closely with internal teams and external partners to ensure clinical through commercial lifecycle activities comply with cGMP regulatory requirements and guidelines. This position reports to the Director of Quality Assurance.
This is a remote position, with working hours aligned to the Eastern Time (EST) zone.
Key Responsibilities:
Provide quality oversight of external manufacturing for both clinical and commercial drug products, including lot disposition.
Review and approve internal and external Deviations, Change Controls, and CAPAs.
Support the review and data verification of clinical regulatory filings.
Collaborate with alliance partners to ensure compliance with their quality systems and practices related to drug product manufacturing and disposition.
Assist in establishing best practices with alliance partners to ensure consistent quality standards.
Partner with internal teams and external vendors to address complex quality issues, ensuring compliant solutions that meet patient needs.
Ensure timely and accurate reporting of key performance indicators (KPIs) and risk metrics.
Drive continuous improvement initiatives to proactively mitigate risks and maintain effective operations to support business needs.
Qualifications:
Bachelor's degree in life sciences, engineering, or a related field.
Minimum of 5 years of experience in a pharmaceutical or biopharmaceutical Quality Assurance role with increasing responsibility.
Experience working with external Contract Manufacturing Organizations (CMOs) in a virtual environment.
Strong knowledge of aseptic techniques and parenteral drug manufacturing operations.
Hands-on GMP management experience, including exposure to regulatory authorities such as FDA, EMA, PMDA, or equivalent.
Experience in Quality Operations roles for both investigational and commercial products is preferred.
Proven experience collaborating with alliance partners to ensure compliance and drive best practices.
Demonstrated ability to identify inefficiencies, improve processes, and enhance turnaround times.
Senior QA QC and Commissioning Specialist
Remote Quality Assurance Auditor Job
Senior QA QC & Commissioning Engineer
DataX Connect are partnered with a global real estate company who are dedicated to making an impactful difference to the data center/ mission critical sector.
Due to outstanding growth and further investments to the business, they are looking to hire an experienced of Senior QA/QC or Electrical Commissioning Engineer to take lead on multiple large data center projects.
The position
The position entails working with a diverse group of internal and external Stakeholders at all levels of the organization, and the individual will require the independent judgement to plan, prioritize, and organize a diverse workload in a fast-paced environment. This successful candidate will be detail oriented with strong organizational skills, and a team player attitude.
Responsibilities
Have fluency with all commissioning processes and deliverables covered in ASHRAE, CSA, and LEED commissioning requirements.
Expertise in electrical equipment/systems installation (means & methods), system startup and pre-functional inspections, acceptance testing and associated commissioning activities.
Work directly with General Contractors, trades, inspectors, AHJs, and others involved with the QA/QC program execution for large critical facility construction and commissioning.
Monitor, review, and execute all facets of Commissioning related projects by providing exceptional technical and field activities.
Perform Commissioning Design Drawing & Specification Reviews, as well as Submittal (shop drawing) reviews.
Qualifications and previous experience
A recognized university degree or equivalent, or at least 5 years of significant and applicable knowledge and experience in data center QA/QC. Engineering Degree is preferred.
A minimum of 7 years of relevant electrical engineering and/or field-testing experience with minimum of 5 years in providing building commissioning and/or construction QA/QC field services for data centers
Why Apply
Join a fantastic group of experienced data center professionals.
Continuous growth throughout the business.
Competitive salary, benefits and bonus.
Benefits
401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Flexible and Remote Work Arrangements may be available
Quality Assurance Specialist
Quality Assurance Auditor Job In Richmond, VA
Responsibilities of this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.
Essential Duties and Responsibilities:
Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to material, bill of material and executed batch record review and approval.
Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
Provide cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
Act as a resource for colleagues.
Lead or participate in Quality Risk Management Processes as needed.
Promote a safety and quality-first mindset in daily job functions.
Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
Maintain current knowledge of FDA requirements to keep pace with evolving requirements for manufacturing.
Support, lead, or approve documents, change controls, investigations and CAPAs to support the Quality Management System.
Quality Assurance/Quality Control Associate
Remote Quality Assurance Auditor Job
We are looking for a Quality Assurance/Quality Control Associate to write or revise quality documentation, assist with raw material qualifications, perform process and final quality inspections and lab testing. You will assist in conducting product extensions. As the Quality Associate, you will be expected to work under general supervision or as part of a multifunctional team on assignments of varying degrees of complexity to ensure products and processes comply with the Company's quality system and applicable regulatory requirements.
Responsibilities:
Write/revise SOP's, work instructions, forms, component specifications, etc. related to QA/QC processes
Write and/or revise raw material component specifications
Write and at times execute product extension and other various studies.
Review and record test data for consistency and accuracy.
Conduct laboratory testing on incoming, in process and finished materials using laboratory equipment, as required.
Record and maintain temperature data for various equipment.
Learn the applicable QC functions as related to the new ERP system.
Interface with operations, R&D and Marcom as a team member to accomplish goals. Work as an ambassador and liaison for QA and other departments.
Cross train in the value assignment process, as to data entry and review. learn the coordination with outside value assignment laboratories.
Complying with cGMP and laboratory safety practices
Perform special projects as assigned by department head or other duties as assigned
Employee will contribute to a positive work environment
Assist in maintaining Quantimetrix Corporation quality system
Qualifications:
Bachelor of Science degree in clinical, biological, or chemical sciences
2+ years' experience working in a clinical or medical device/IVD laboratory or an FDA regulated quality assurance medical device or pharmaceutical manufacturing environment
Ability to write technical reports and/or studies
Ability to analyze and present data in a coherent and scientific manner
Excellent communication skills (both verbal and written)
Basic use of Excel spreadsheets and statistics
Detail oriented
Experience working under FDA/ISO regulations
Best-in-Class Benefits and Perks:
We value our employees' time and efforts. Our commitment to your success is enhanced by competitive compensation of $30-35/hour, depending on experience, and an extensive benefits package including:
Comprehensive health coverage: Medical, dental, and vision insurance provided
Robust retirement planning: 401(k) plan available with employer matching
Financial security: Life and disability insurance for added protection
Flexible financial options: Health savings and flexible spending accounts offered
Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
Join us on the journey of excellence and innovation. Apply now and be a part of something extraordinary!
Ready to take the lead in our manufacturing revolution? If you're excited to drive change, inspire a team, and make a lasting impact, we want to hear from you!
We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.
Consultant Quality Assurance Manager/Assoc Director
Remote Quality Assurance Auditor Job
About the Company: Propedix is a biopharma and consumer health company dedicated to advancing innovative treatments in healthcare. Our flagship product, featuring our breakthrough anti-fungal and drying agent technology, launches in Q2 2025, with a pipeline of advanced OTC and Rx treatments in dermatology and health. Driven by strong research and development, we're delivering the next generation of health solutions.
Position: Consultant Quality Assurance Manager/Assoc Dir
Position Overview: The Quality Assurance Manager/Director will be responsible for ensuring the highest standards of quality throughout the product development lifecycle. This role is pivotal in preparing for the commercial launch in 2025 of an Over-The-Counter (OTC) athlete's foot treatment by working closely with our Contract Manufacturing Organization (CMO) to develop and finalize critical quality documentation. The ideal candidate will have a solid background in biopharmaceuticals, experience with regulatory compliance, and the ability to manage complex QA activities that support the manufacturing and launch of new products.
Key QA Manager Responsibilities
Quality Documentation Preparation & Review: Lead the preparation, review, and finalization of essential quality assurance documentation to meet the regulatory requirements for commercial launch. This includes Vendor Qualification and Audits, Standard Operating Procedures (SOPs), and release protocols.
CMO Management and Oversight: Serve as the primary point of contact between internal teams and CMOs for all quality-related matters. Coordinate with external partners to ensure that manufacturing processes align with the company's quality standards and regulatory requirements, including cGMP (current Good Manufacturing Practices).
Regulatory Compliance: Ensure that the company's products and processes are compliant with global regulatory standards, including FDA and other relevant health authorities. Support the preparation and submission of quality-related documents for any OTC level regulatory filings.
Risk Management: Identify potential quality risks early in the development process, especially related to manufacturing and supply chain, and collaborate with relevant teams to mitigate these risks before the commercial launch.
Product Release & Commercial Launch: Oversee the release of products for clinical trials and the commercial market, ensuring that all batch release documentation and certifications are accurate and complete for the timely launch of the product in April 2025.
Internal Quality Audits & Inspections: Manage internal OTC standard quality audits and regulatory inspections, ensuring compliance with all internal and external quality requirements. Support preparation for inspections by regulatory authorities and third-party audits.
Cross-Functional Collaboration: Collaborate closely with Product Development, Regulatory Affairs, Manufacturing, and Supply Chain teams to ensure quality requirements are met at each stage of the product lifecycle, from development through to commercial launch.
Location: Virtual, but MUST reside in Southern California. Work can be performed remotely with attendance required for live meetings once a month. Travel out of region (in U.S.) expected 3 to 4 times a year.
Experience/ Necessary Skills
Education: Bachelor's or Master's degree in Life Sciences, Chemistry, Engineering, or a related field. Advanced degree or certifications (e.g., ASQ, Six Sigma) is a plus.
Experience:
Experience with OTC biopharma and consumer system and quality standards required.
5+ years of experience in quality assurance within the biopharmaceutical or biotechnology industry, with a focus on cGMP-compliant manufacturing.
Proven experience working with CMOs in preparing for commercial product launches, including development of quality-related documentation (BPRs, SOPs, Master Batch Records, etc.).
Strong understanding of regulatory guidelines (FDA, OTC) and quality systems.
Hands-on experience with risk management, CAPA (Corrective and Preventive Actions), and change control processes.
Skills & Competencies:
In-depth knowledge of biopharmaceutical manufacturing processes and quality systems.
Strong project management skills and the ability to prioritize and manage multiple tasks in a fast-paced environment.
Knowledge and experience with OTC quality standards.
Proficiency in quality management software, document control systems, and MS Office Suite.
Hours: Approx 10 hours a week for first 10 weeks, then 6 hours a week thereafter. Candidates must be available for live meetings and email correspondence on average 1 hours a day during normal business hours. Attendance at a once a week management meeting (usually scheduled for Tuesday) a requirement.
Compensation. $5,000 per month for first 10 weeks than $3,500/mo thereafter . This is an independent contractor 1099 position. Potential LTI stock options awarded after 3 months.
Support and Supervisor: Position will report to the CEO who will be their administrative supervisor. This position is expected to work closely on a daily basis with the CTO/VP of Product Development, Sr. Director of Manuf, Chair of Scientific Advisory Board, CCO, and all 3rd party production and component vendors.
Application: Interested parties should send their resume, brief cover note, and their LinkedIn profile to Nicole Lewis, at ******************.
Information Technology Auditor
Remote Quality Assurance Auditor Job
Blue Chip Talent is an award-winning, woman-owned staffing company that works hard to “Advance Careers Daily”.
We pride ourselves on building lasting relationships. We do this through our unique ongoing touchpoint program, personalized orientation, bi-yearly appreciation lunches, company-sponsored charitable events, and our flagship family Woodward Dream Cruise event.
We also offer industry-leading benefit options:
Four (4) healthcare plans to choose from
PTO & Paid Holidays
Dental & Vision insurance
Company-paid life insurance
Long and short-term disability
401k with yearly arbitrary match
Pet insurance
You can count on Blue Chip Talent to be your reliable career coach and advocate. We look forward to connecting with you and guiding you on your career goals.
This is a Tier 1 focused role, hybrid remote work schedule. 2nd shift only
What you'll be doing:
Conduct comprehensive audits of IT systems, applications, and infrastructure to ensure compliance with regulatory standards, internal policies, and industry best practices.
Evaluate the effectiveness of security controls, risk management frameworks, and IT governance processes to mitigate risks and ensure operational resilience.
Prepare detailed audit reports with actionable recommendations to enhance system integrity, data confidentiality, and overall IT performance.
Need to have:
5+ years of IT audit
Cobit, NIST, ISO experience
Nice to have:
Degree
Certifications
Financial industry experience
*Blue Chip Talent will not be sponsoring visas or accepting C2C for this position at this time.
Blue Chip Talent is an Equal Opportunity Employer (EOE) that values merit-based recruitment centered around technical ability, skillset, and personality/cultural fit with our employing partners.
Outpatient Coding Auditor (PRN)
Remote Quality Assurance Auditor Job
CSI Companies is actively seeking REMOTE Outpatient Auditors with one of our clients, a leading non-profit hospital system that is taking the level of care to the next level! Candidates may sit anywhere in the United States. This is a contract, remote Inpatient coding opportunity.
Position Overview:
PRN Consulting position; part-time hours available.
100% Remote position - nationwide.
Responsible for independently reviewing coded data quality through ongoing analysis and evaluation of outpatient records. .
Performs con-current audits on accuracy of APC, ASC or MS-DRGs as well as on quality of medical record documentation needed for accurate coding.
Prepare reports and performs constant tracking and trending of audit results as well as prepare presentations for Coding Staff education.
Create consistency and efficiency in outpatient claims processing and data collection to optimize APC, ASC or DRG reimbursement.
Performance standards: Maintains 95% coding accuracy rate and 95% accuracy rate and maintains designated productivity standards
Will require high-speed home internet connections and a quiet home office environment free from distractions.
Responsibilities:
Will audit inpatient hospital charts for up to 10 inpatient coders.
Ensuring diagnostic and procedure codes are assigned accurately to inpatient encounters based upon documentation within the electronic medical record while maintaining compliance with established rules and regulatory guidelines.
Maintains and achieves departmental standards of coding quality by assigning accurate ICD-10-CM/ICD-10-PCS and CPT codes and APC assignment utilizing an electronic encoder application in accordance with hospital policy and regulatory body guidelines.
Reviews medical records to identify recovery opportunities on claims for outpatient facility, professional, and other allied health services.
Provides a detailed rationale, including supporting references, for every review resulting in an outpatient findings letter.
Maintains and achieves departmental standards of abstracting quality by reviewing the discharge disposition entered by nursing and corrects if necessary, in order to achieve the highest quality of entered data.
Assigns and enters physician identification number and procedure date correctly in the medical record abstracting system.
Responsible for assigning diagnostic and procedural codes to encounters of high complexity.
Maintains 95% coding accuracy rate and 95% accuracy rate for MS-DRG assignment and maintains site designated productivity standards.
Maintains minimum production of 1 chart per hour or site specific productivity standards.
Demonstrates excellent written and verbal communications skills.
Communicates professionally with co-workers, management, and hospital staff regarding clinical and reimbursement issues.
May be responsible for auditing the work of less experienced coders.
Perform other related duties as assigned.
Qualifications:
A minimum of 2-5 years of coding/auditing experience in a hospital and/or coding consulting role.
Experience in computerized encoding and abstracting software.
Associate or Bachelor' degree from AHIMA certified HIM Program or Nursing Program or completion of certificate program with CCS preferred.
Must have at least one of the following certs: CCS, RHIA or RHIT.
Proficient in ICD10CM/PCS, CPT4, and HCPCS coding conventions and guidelines.
Proficient in MS Word, Excel and PowerPoint.
Aside from a benefits package that is a cut above the rest, you will gain access to an award-winning company culture. Want to see for yourself?
With CSI, you will gain access to….
Healthcare coverage plus HSA matching
Onsite corporate gym with Wellness Challenges with incentives & rewards for participation
Participation in 401(k) retirement plan
Competitive compensation plans with a generous PTO policy.
An award-winning corporate culture
The CSI Companies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws
Internal Auditor II
Quality Assurance Auditor Job In Winchester, VA
To contribute to the execution of operational audits across Navy Federal's business units. Identify, and evaluate risks and test key controls in the business. Follow industry standards in the planning, execution and documentation of audit engagement. Participate in other assignment as needed such as issues closure validation and issue monitoring. Promote partnership, trust, and accountability within Internal Audit and build deeper relationships with our audit stakeholders.
Talent Quest
This position is eligible for the TalentQuest employee referral program. If an employee referred you for this job, please apply using the system-generated link that was sent to you.
Responsibilities
Conduct integrated operational audits in accordance with Navy Federal and industry audit standards
Assist the Auditor-In-Charge in identifying and assessing risks to develop and execute a risk-based audit work program
Coordinate with points of contact and first/second lines of defense to conduct preliminary research, participate in and occasionally lead process walkthroughs, document process narratives and workflows, identify risks and key controls, and obtain audit evidence for testing
Brainstorm ideas for leveraging data analytics and technology to drive deeper risk coverage and insights to business partners
Perform control testing across multiple audits concurrently. Apply critical thinking skills by seeking to understand and execute assigned control testing and document results according to professional and internal standards
Independently review and analyze audit evidence and results of testing to determine design and operating effectiveness of controls.
Identify and summarize potential issues and discuss with the Auditor-In-Charge in a timely manner
Prepare audit workpapers to document relevant information obtained, analyzed, and evaluated that support audit observations/issues and conclusions
Self-manage workload/timelines and report delays and issues to audit management
Participate in Internal Audit strategic initiatives and act as a champion of change and continuous improvement
Perform other duties as assigned
Qualifications
Minimum one year of experience in internal audit, external audit or advisory services
Working knowledge of internal control concepts and practices and risk-based auditing techniques
Effective skill in managing multiple priorities independently and operate well in a team environment to achieve goals
Effective interpersonal and communication skills
Effective organizational, planning and time management skills
Effective word processing and spreadsheet software skills
Effective critical thinking, analytical, and problem-solving skills
Bachelor's degree or the equivalent combination of experience, education, and training
Desired Qualifications
Experience with credit union financials and/or regulations
Working Knowledge of NFCU products, services, programs, policies, and procedures
Public accounting experience
Certified Internal Auditor (CIA), Certified Public Accountant (CPA) and/or Certified Information Systems Auditor (CISA) or working towards one of these certifications
Hours: Monday - Friday, 8:00AM - 4:30PM
Locations: 820 Follin Lane, Vienna, VA 22180 | 5550 Heritage Oaks Drive Pensacola, FL 32526 | 141 Security Drive Winchester, VA 22602
About Us
Navy Federal provides much more than a job. We provide a meaningful career experience, including a culture that is energized, engaged and committed; and fierce appreciation for our teams, who are rewarded with highly competitive pay and generous benefits and perks.
Our approach to careers is simple yet powerful: Make our mission your passion.
Best Companies for Latinos to Work for 2024
Computerworld Best Places to Work in IT
Forbes 2024 America's Best Large Employers
Forbes 2024 America's Best Employers for New Grads
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Fortune Best Workplaces for Millennials 2024
Fortune Best Workplaces for Women 2024
Fortune 100 Best Companies to Work For 2024
Military Times 2024 Best for Vets Employers
Newsweek Most Loved Workplaces
2024 PEOPLE Companies That Care
Ripplematch Recruiting Choice Award
Yello and WayUp Top 100 Internship Programs
From Fortune . 2024 Fortune Media IP Limited. All rights reserved. Used under license. Fortune and Fortune Media IP Limited are not affiliated with, and do not endorse products or services of, Navy Federal Credit Union.
Equal Employment Opportunity: Navy Federal values, celebrates, and enacts diversity in the workplace. 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.
Hybrid Workplace: Navy Federal Credit Union is a hybrid workplace, and details will be discussed during your interview process.
Disclaimers: Navy Federal reserves the right to fill this role at a higher/lower grade level based on business need. An assessment may be required to compete for this position. Job postings are subject to close early or extend out longer than the anticipated closing date at the hiring team's discretion based on qualified applicant volume. Navy Federal Credit Union assesses market data to establish salary ranges that enable us to remain competitive. You are paid within the salary range, based on your experience, location and market position
Bank Secrecy Act: Remains cognizant of and adheres to Navy Federal policies and procedures, and regulations pertaining to the Bank Secrecy Act.RequiredPreferredJob Industries
Other
Internal Auditor II (Remote)
Remote Quality Assurance Auditor Job
Piper Companies is searching for an Internal Auditor II for a managed care organization in North Carolina. The Internal Auditor II will serve as senior advisor for consultation, preparation of audit programs and strategy. This is a remote full time, direct placement position.
Candidate must reside in NC.
Responsibilities of the Internal Auditor II:Lead internal audit initiatives and improvement initiatives Independent review of work files and financial documents Evaluate and improve governance, risk management, and internal controls Contribute to risk assessment and annual audit planning and execution Qualification of the Internal Auditor II:Bachelor's degree in Accounting, Business, or a related field of study + 7 years of experience Master's degree in Accounting, Business, or a related field of study + 5 years of experience3+ years' experience in Managed Care or government in a compliance or audit capacity One of the these certifications are required CIA, CPA, CFE, AHFI, CHC or CRMAMust reside in North CarolinaCompensation of the Internal Auditor II:$90,000-$105,000/year depending on experience Comprehensive Benefits including Medical, Dental, Vision, 401k, PTO, Sick Leave if required by law, & HolidaysThis job opens for applications on 1/21/2025.
Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Internal auditor, auditor, managed care, MCO, review, compliance, reporting, policies, standards, strategy, engagement scope, risk management, risk assessment, regulation, communication, Medicaid, claims processing, utilization review, contracting, data, investigative, hybrid, Raleigh, Durham, North Carolina, NC#LI-PB2 #LI-Remote
Quality Assurance Manager (SQF)
Quality Assurance Auditor Job In Richmond, VA
As the SQF Quality Assurance Manager, you will oversee food packaging quality and plant safety programs, ensuring compliance with SQF Level 2 HACCP Certification and regulatory standards. You will lead continuous improvement initiatives, maintain certifications, and manage quality and safety systems at our VA facility.
About the Role:
In this opportunity as a SQF Quality Assurance Manager, you will:
Serve as the site quality and safety champion, driving improvements in metrics and achieving quality KPIs.
Ensure compliance with SQF Level 2 HACCP Certification, GMP standards, and customer specifications.
Lead audits, including internal SQF and third-party inspections, and implement corrective actions.
Develop and sustain food packaging safety and quality processes, collaborating with the HACCP team to ensure compliance.
Conduct safety and quality training for employees and new hires.
Lead Continuous Improvement initiatives and the facility's safety committee.
Perform root cause analysis, issue corrective actions, and address supplier claims related to defective materials.
Collaborate with management to set and achieve quality benchmarks.
About You:
You're a fit for the role of SQF Quality Assurance Manager, if your background includes:
Must have a bachelor's degree or equivalent experience.
Must be a certified SQF Practitioner with HACCP.
Minimum of 3 years' experience in the manufacturing process of food-safe packaging.
Proficiency in Microsoft Office, particularly Excel, Word, and Outlook.
Strong leadership, organizational, and time management skills.
Effective communication and problem-solving abilities.
Ability to work both independently and as part of a team.
What We Offer:
A dynamic and collaborative work environment.
Opportunities for professional growth and development.
A chance to make a significant impact on food packaging quality and safety.
Please note: Third-party staffing agencies are kindly requested to refrain from contacting our hiring managers regarding this or any other role, as we are not accepting solicitations or applications from agencies.
Oliver Inc is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, gender, gender identity and expression, sex, sexual orientation, disability, age, citizenship status, veteran status or any other characteristic protected by applicable federal, state or local laws.
Quality Assurance Laboratory Technician
Quality Assurance Auditor Job In Roanoke, VA
The Quality Lab Technician works closely with manufacturing and our customer base to ensure that customer quality expectations are met or exceeded. The technician also ensures that the facility operates within regulatory guidelines. The Quality Lab Technician oversees the day-to-day activities of the in-process bulk laboratories.
PRIMARY RESPONSIBILITIES
Review bulk and finished products that Beauty Company manufactures.
Prepare dyes into a percent solution formula for product coloring.
Ensure the correct specification for adding color to the formula.
Provide specifications to the compounder to color the batches.
Take samples of finished bulk products and finished goods to test for pH, viscosity, odor, color, and appearance (cloudiness).
Determine if samples match specifications; issue Nonconformance Reports (NCMR) for rejected samples and notify Customer Service, Purchasing, and the customer.
Generate Certificates of Analysis (CofA) for any bulk products leaving the building.
Retest bulk as needed for color, odor, and appearance, and update status in AS400. Notify Customer Service and the customer of any nonconformances via NCMR.
Write NCMRs for non-conforming and expired raw materials.
Maintain standards and samples.
Enforce Current Good Manufacturing Practices (CGMPs) and company policies.
Perform other duties as needed or assigned.
Recertify annually as a "Certified Nose" and "Certified Color Vision" through designated tests.
DESIRED MINIMUM QUALIFICATIONS
Ability to read, write, and perform basic mathematical calculations.
Ability to use a counting scale and RF scanner.
Proficiency in Microsoft Office programs, AS400, and various customer databases.
Ability to work in a team-oriented environment and willingness to assist and train others.
Demonstrate safe behavior and support department/plant safety goals in a continuous improvement process.