Quality Manager
Quality manager job in Landisville, PA
Job Description
Quality Manager ⏰ Work Hours: ???? Competitive Compensation
Bearon Manufacturing LLC, a proud affiliate of The Dixon Group, is seeking a dynamic and conscientious Manager of Quality Control to lead our quality function in Landisville, PA! This is a critical leadership role that manages both Quality Assurance (QA) and Quality Control (QC) in a busy and growing production environment. If you are a collaborative leader driven by continuous improvement, defect elimination, and risk prevention, you will thrive here. You will partner closely with Manufacturing, Procurement, Engineering, and Customer Service teams to maintain our high standards of excellence.
Who We Are: Bearon Manufacturing LLC is a U.S.-based precision components company with over 40 years of experience. We specialize in machining, casting, prototyping, pattern making and value-added finishing services, operating from a modern facility in Pennsylvania. Our parts serve a wide range of industries including agriculture, emergency equipment, medical, filtration, transportation and ship-building. We're proud of our long-standing commitment to quality, continuous improvement and supporting our customers with industry-leading manufacturing solutions.
At Bearon Manufacturing LLC, we value the contributions of our Military Veterans and proudly employ our nation's heroes. Veterans are strongly encouraged to apply.
⚙️ What You'll Do:
As the Quality Manager, you will be the ultimate owner and driver of quality throughout our entire operation.
Rapidly develop and maintain full ownership of the division's Quality Management System (QMS).
Define and enforce procedures for incoming raw material acceptance, in-process evaluation, and final product inspection and testing.
Ensure QMS compliance by providing comprehensive training to affected personnel and conducting regular internal audits.
Lead the investigation and corrective action process for significant defects, quality notifications, and customer complaints/surveys.
Administer, direct, and mentor test lab personnel, fostering a high-performance team.
Ensure the precise maintenance and calibration of quality control instruments, including gages and testing equipment.
Closely monitor all production processes to ensure strict conformance with product tolerances and specifications.
Drive organizational focus on reducing the Cost of Poor Quality (COPQ) through targeted initiatives that minimize waste, scrap, and rework.
Regularly prepare and present detailed reports on program progress, investigation findings, Root Cause Analysis (RCA), and corrective actions to the Division Leadership Team.
???? What We're Looking For:
A Bachelor's Degree in a relevant field OR 5-7 years of highly relevant work experience in a quality leadership capacity.
A minimum of 3-5 years of direct experience in a quality role within a manufacturing or production environment.
Proven experience successfully leading and mentoring a quality team.
In-depth knowledge of Quality Management Systems (QMS), quality assurance methodologies, measurement instruments, and quality manufacturing processes.
Demonstrated experience with Foundry, casting knowledge, manufacturing, or machine shop operations.
Exceptional data analysis, critical thinking, problem-solving, and statistical skills.
Must have successfully implemented or maintained ISO 9001 and/or AS9100 standards.
Proficiency with relevant quality management software and data reporting tools.
Outstanding written and verbal communication and interpersonal skills.
Six Sigma certification (e.g., Green or Black Belt) is highly preferred.
???? What We Offer:
Medical, dental, and vision insurance for you and your family
Competitive salary
Bonus programs
401K retirement plan
Training opportunities
Tuition reimbursement
Paid vacation, PTO, and holidays
Gym reimbursements, and more!
Join us and be a part of a team that values your contributions and supports your goals!
The Dixon Group is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices and laws. Accordingly, to the fullest extent required by applicable law, The Dixon Group strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons.The Dixon Group is committed to protecting the privacy rights of its employees and job applicants to the fullest extent required by applicable law. To that end, personal information will be collected solely for those legitimate business purposes recognized by law, and then maintained in a manner consistent with all applicable laws and regulations pertaining to document retention requirements. The Dixon Group does not sell personal information to third parties, and does not share such personal information with third parties except when authorized by law to do so (e.g., in response to a lawful subpoena; mandatory tax reporting; etc.) Please contact us at ************** or ***************** if you need help to participate fully in the application process.
Easy ApplyFood Safety and Quality Manager
Quality manager job in Womelsdorf, PA
Employee Type: Full time Job Type: Quality Job Posting Title: Food Safety and Quality Manager About Us: TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of over 20 production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are investing in talent and creating a performance-based culture where employees can do their best work and develop their careers, directly impacting our mission to make high quality, affordable food for our customers, communities, and families. We hope you will consider joining the team and being part of our future.
Named one of America's Best Large Employers by Forbes Magazine, we are proud to live by a strong set of values and strive to "Engage and Delight - One Customer at a Time." Guided by our values-Own It, Commit to Excellence, Be Agile, Speak Up, and Better Together. We are a diverse team driven by integrity, accountability, and a commitment to exceptional results. We embrace change, prioritize continuous learning, and foster collaboration, transparency, and healthy debate. Together, we set each other up for success to achieve enterprise-wide goals.
What You Gain:
* Competitive compensation and benefits program with no waiting period - you're eligible from your first day!
* 401(k) program with 5% employer match and 100% vesting as soon as you enroll.
* Comprehensive paid time off opportunities, including immediate access to four weeks of vacation, five sick days, parental leave and 11 company holidays (including two floating holidays).
* Leaders who are invested in supporting your accelerated career growth, plus paid training, tuition reimbursement and a robust educational platform - DevelopU - with more than 10,000 free courses to support you along the way.
* An inclusive working environment where you can build meaningful work relationships with a diverse group of professionals. Take advantage of opportunities to build on our team-oriented culture, such as joining one of our Employee Resource Groups.
* Access to our wellness and employee assistance programs.
Job Description:
About the Role:
As the site Food Safety and Quality Manager, you will oversee and ensure the implementation of Quality Assurance (QA) programs for the Womelsdorf, PA site, a manufacturer of confections. This role upholds product quality, food safety, and sanitation in compliance with company standards and regulatory requirements.
You'll add value to this role by performing various functions including, but not limited to:
* Oversee, implement, and maintain QA programs, including Formula Control, Allergen Control, Non-Conforming Products, Recalls, Food Safety Plans, and pest control systems.
* Develop, implement, and manage comprehensive sanitation programs for daily and periodic cleaning of the facility.
* Define and enforce best laboratory practices and quality policies.
* Ensure compliance with company, state, and federal sanitation regulations.
* Collaborate with R&D to improve product quality and cost-effectiveness, support product changes, and oversee plant testing.
* Coach, mentor, and develop quality and sanitation leaders/supervisors in addition to providing quality and food safety training for employees at all levels.
* Conduct quality and sanitation audits and summarize technical data to identify trends and corrective actions as well as, support quality systems and initiatives.
* Serve as the plant's liaison for regulatory authorities, including USDA, FDA, and third-party auditors.
Important Details:
* This is a full-time, on-site role on our first shift. Occasional flexibility is required to support alternate shifts.
You'll fit right in if you have:
* Bachelor's degree in food science, Biology, or a related field. SQF Practitioner certification and Food Defense Program leadership experience preferred.
* Minimum of 5 years of supervisory experience in a food manufacturing environment.
* In-depth knowledge of sanitation practices, GMPs, FDA/USDA regulations, and third-party audits.
* Hands-on experience with GFSI certification, CFR expectations, pre-operational inspections, and SPC systems.
* Demonstrated problem solving, leadership, and analytical skills.
* Experience in creating, executing, and monitoring manufacturing technical standards and procedures.
* Experience using Microsoft Office.
Your TreeHouse Foods Career is Just a Click Away!
Click on the "Apply" button or go directly to ****************************** to let us know you're ready to join our team!
At TreeHouse Foods, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work to help us "Engage and Delight - One Customer at a Time". TreeHouse Foods is an Equal Opportunity Employer that prohibits discrimination or harassment of any type. All qualified applicants are considered for employment without regard to race, color, national origin, age, sex, sexual orientation, gender, gender identity or expression, disability status, protected veteran status, or any other characteristic protected by law. Applicants who require an accommodation to participate in the job application or hiring process should contact disability-accommodations@treehousefoods.com
TreeHouse Use Only: #IND1
Auto-ApplyBakery Quality Manager
Quality manager job in Denver, PA
Since 1869, we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Swanson, and V8.
Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us.
Why Campbell's…
Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners).
Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting.
Campbell's offers unlimited sick time along with paid time off and holiday pay.
If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store.
Giving back to the communities where our employees work and live is very important to Campbell's. Our “Campbell's Cares” program matches employee donations and/or volunteer activity up to $1,500 annually.
Campbell's has a variety of Employee Resource Groups (ERGs) to support employees.
How you will make history here…
The Bakery Quality Manager has specific compliance, process, and consumer quality responsibilities for the Bakery business unit and compliance / audit readiness for the site. This position will manage a matrix relationship with the Senior Quality Manager and Plant Manager to in‐fluence senior management on alignment of Quality strategies, Quality annual objectives, and project plans. Individual will coordinate and deploy Quality Assurance programs and influence plant leadership with quality best practices.
What you will do…
Principal Accountabilities:
• 30% - Develop, drive, and continually improve a comprehensive quality program as defined by the Campbell's Snack QPM and CSC North American Quality Policies. (Compliance Quality)
• 20% - Drive process improvement initiatives through staff, workgroup, Campbell's Snack Quality staff, and R&D (Process/Food Quality)
• 20% - Lead site compliance and audit readiness for all BUs (Cookies, Crackers, Bakery)
• 15% - Manage team by establishing goals, objectives, individual development plans and coaching.
• 10% - Manage & Drive Consumer Complaint programs, initiatives, and consumer delight models.
• 5% - Support programs across Safety, People, Quality, Delivery and Cost.
Job Complexity / Scope:
• Response to new or changes in regulations on specifications, procedures, quality, and implications utilized in a range of finished product.
• Troubleshooting quality issues across the varied supply chains for ingredients, packaging, materials, and finished products supplied (examples; mixed labels, allergen risk management, equipment risk management, container nonconformance).
• Expert abilities and decision quality in Food Safety, Regulatory, and Quality Systems and their application within food processing. Facilitate and/or direct resolution to issues as it relates to food safety and quality.
• Expert knowledge in Sanitation and GMP Practices, familiarity with Pest Control programs and techniques
• Knowledge of Quality Standards, and Quality Policies, with skills and ability to execute against requirements.
• Knowledge and general business acumen to support and influence Manufacturing, including best practices and innovative technologies.
• Knowledgeable in industry Food Safety/Quality audit practices, and skilled in adapting to achieve business best practices.
• Capable of engaging other business units in the development and standardization of: Quality manuals, policies, procedures, and data templates, audit standards and procedures, and Quality Key Performance Indicators.
• Knowledgeable in Statistical Process Control programs and Process capability studies.
• Ensures personnel are technically capable of handling non-routine quality system issues and that issues are investigated, documented, and resolved.
• Record of leadership and demonstrated success in collaborative development, documentation, planning, and implementation and continuous improvement of quality systems.
• Ability to drive organizational alignment on Quality objectives with an enterprise-wide mindset, and the adaptation of structure, processes, and systems to achieve objectives.
• Capable of influencing development steps used in the Innovation and Commercialization process to leverage Design in achieving consumer safety and quality objectives.
• Assertive, outspoken, yet collaborative. Demonstrated skills influencing components of the business, tough-mindedness, vision, and political savvy to manage internal and external relationships and situations.
• Dedicated work habits, takes initiative, sets high standards Knowledgeable and capable of collaboration on quality pro‐ grams; drives improvement of consumer-based specifications. Aware of Continuous Improvement tools.
• Ability to manage, coach, and develop people, talent, and skills needed for the job.
• Ability to demonstrate and execute against the Campbell leadership model behaviors of Inspire Trust, Create Direction, Drive Decision Making, Build Talent & Culture, execute with Excellence, and Own the Results.
Who you will work with…
You will work with the Quality, Sanitation and other teams in the bakery business unit in the plant.
What you bring to the table (must haves) …
Bachelor's degree, preferably in Food Science or related
4 years' experience in food industry quality plant / systems experience with demonstrated achievement in Quality Leadership
It would be great to have (nice to haves)…
PCQI (Preventive Control Qualified Individual), HACCP (Hazard Analysis Critical Control Point) certified, SQF (Safe Quality Foods) certified strongly preferred
Up to 10 % travel.
Compensation and Benefits:
The target base salary range for this full-time, salaried position is between
$85,200-$122,500
Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package.
The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.
Auto-ApplyDirector of Quality
Quality manager job in Lancaster, PA
Director of Quality - Remote (Lancaster, PA Region) Industry: Printed Circuit Board (PCB) Manufacturing Are you ready to lead quality excellence in PCB manufacturing? Our client is seeking a Director of Quality to shape their quality strategy, drive continuous improvement, and uphold their reputation for precision and reliability. This is a unique succession opportunity-you'll work side-by-side with their current Director of Quality, an industry veteran, gaining hands-on mentorship and decades of expertise before stepping fully into this key leadership role.
What You'll Do
Lead strategic quality initiatives, ensuring product excellence and customer satisfaction.
Act as the primary contact for customer and supplier quality concerns, driving timely resolutions.
Maintain and enhance ISO certification and compliance documentation.
Oversee supplier qualification and performance metrics, ensuring adherence to industry standards.
Develop and improve quality policies, processes, and corrective action systems.
Collaborate across departments to promote proactive quality improvement.
Represent in audits, customer reviews, and vendor evaluations.
What You'll Bring
5+ years in quality management or supplier quality within manufacturing (PCB experience strongly preferred).
Strong communication and leadership skills.
Proven track record in ISO compliance, corrective action systems, and continuous improvement.
Experience analyzing supplier performance data and implementing process enhancements.
Technical proficiency in interpreting drawings, Gerber files, and quality specifications.
Hands-on understanding of manufacturing processes, inspection techniques, and quality documentation.
Associate's or Bachelor's degree in engineering, manufacturing, or quality.
Apply Today
Email your resume to Joe Saunders at *************************.
Easy ApplyDirector, Global Quality GMP Processes
Quality manager job in Harrisburg, PA
The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality processes** across the organization. This role ensures that product quality systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement** across all regions and product lines.
The Director will lead global initiatives to harmonize and enhance processes related to **product quality complaints, deviations, CAPA, and management reporting** , ensuring timely and effective resolution and robust compliance.
**Key Responsibilities**
+ Global Process Ownership: Lead the design, implementation, and continuous improvement of global quality processes for:
+ Product Quality Complaints
+ Corrective and Preventive Actions (CAPA)
+ Deviations
+ Management Reporting and Trending
+ Benchmarking & Best Practices: Evaluate internal and external quality practices to identify and implement best-in-class solutions that enhance compliance and operational efficiency.
+ GMP Compliance: Ensure all quality processes meet global regulatory requirements (e.g., FDA, EMA, PMDA) and align with current GMP standards.
+ Governance & Standardization: Develop and enforce global standards, SOPs, templates, and tools to ensure consistency across all manufacturing sites and affiliates.
+ Quality Systems Leadership: Oversee the global deployment and optimization of electronic quality systems (e.g., TrackWise), including configuration, training, and validation.
+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment and effective execution of quality strategies.
+ Data-Driven Insights: In collaboration with Quality Operations, lead the development of global quality metrics and dashboards to monitor performance, identify trends, and support decision-making.
+ Team Leadership: Build and lead a high-performing global team of quality professionals, fostering a culture of accountability, innovation, and excellence.
**Qualifications**
Required
**Required Qualifications:**
+ Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences); advanced degree preferred.
+ Minimum 12 years of experience in pharmaceutical quality assurance or quality systems, with at least 5 years in a global leadership role.
+ Deep understanding of GMP regulations and global regulatory requirements (e.g., 21 CFR Parts 210, 211, 820).
+ Proven experience in managing global quality systems and optimizing complaint, CAPA, and deviation processes.
+ Strong analytical and problem-solving skills with a data-driven mindset.
+ Excellent communication, leadership, and stakeholder management skills.
+ Proficiency in quality management systems (e.g., TrackWise) and Microsoft Office tools.
+ Ability to travel internationally as needed.
Preferred
+ Basic understanding of artificial intelligence and advanced analytics
+ Experience supporting risk management programs or frameworks.
+ Familiarity with quality management systems and digital tools.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Director, Quality - Life Sciences
Quality manager job in Harrisburg, PA
Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
Datavant is seeking a strategic and hands-on **Director of Quality** to lead product and supplier quality assurance efforts within our **Life Sciences business unit** , which includes the **Datavant Connect** and **Aetion Evidence Platform** . These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics.
As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards.
This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments.
**What You Will Do**
+ Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance.
+ Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring.
+ Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation.
+ Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring.
+ Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives.
+ Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners).
+ Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP.
+ Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation.
+ Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3).
+ Represent Datavant's quality program in external communications, including client onboarding, RFIs, and quality-related escalations.
**What You Need to Succeed**
+ 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations.
+ Strong working knowledge of relevant regulations and frameworks, including **FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA** , and **GDPR** .
+ Proven leadership in scaling and operationalizing a **QMS in a SaaS, RWD, or GxP context** .
+ Experience managing and mentoring cross-functional teams.
+ Demonstrated success overseeing **validation, supplier oversight, internal audits, and CAPA management** .
+ Deep understanding of **data governance, privacy, and security** best practices.
+ Experience interacting with external auditors, customer compliance teams, or regulatory agencies.
+ Strong communication skills-capable of explaining complex quality topics to product, legal, technical, and customer-facing stakeholders.
**What Helps You Stand Out**
+ Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions.
+ Background working in or with tokenization, health data linkage, or privacy-enhancing technologies.
+ Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams.
+ Training or certification in Six Sigma, ISO Auditing, or software validation methodologies.
+ Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl).
+ Experience contributing to industry working groups on quality, data integrity, or health data compliance.
\#LI-BC1
We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services.
The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation.
The estimated base salary range (not including variable pay) for this role is:
$165,000-$230,000 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (************************************************** . Know Your Rights (*********************************************************************** , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (************************************************************** Id=**********48790029&layout Id=**********48795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (******************************************************************************************************* . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy (**************************************** .
Quality Manager
Quality manager job in Landisville, PA
Work Hours: Competitive Compensation Bearon Manufacturing LLC, a proud affiliate of The Dixon Group, is seeking a dynamic and conscientious Manager of Quality Control to lead our quality function in Landisville, PA! This is a critical leadership role that manages both Quality Assurance (QA) and Quality Control (QC) in a busy and growing production environment. If you are a collaborative leader driven by continuous improvement, defect elimination, and risk prevention, you will thrive here. You will partner closely with Manufacturing, Procurement, Engineering, and Customer Service teams to maintain our high standards of excellence.
Who We Are: Bearon Manufacturing LLC is a U.S.-based precision components company with over 40 years of experience. We specialize in machining, casting, prototyping, pattern making and value-added finishing services, operating from a modern facility in Pennsylvania. Our parts serve a wide range of industries including agriculture, emergency equipment, medical, filtration, transportation and ship-building. We're proud of our long-standing commitment to quality, continuous improvement and supporting our customers with industry-leading manufacturing solutions.
At Bearon Manufacturing LLC, we value the contributions of our Military Veterans and proudly employ our nation's heroes. Veterans are strongly encouraged to apply.
️ What You'll Do:
As the Quality Manager, you will be the ultimate owner and driver of quality throughout our entire operation.
* Rapidly develop and maintain full ownership of the division's Quality Management System (QMS).
* Define and enforce procedures for incoming raw material acceptance, in-process evaluation, and final product inspection and testing.
* Ensure QMS compliance by providing comprehensive training to affected personnel and conducting regular internal audits.
* Lead the investigation and corrective action process for significant defects, quality notifications, and customer complaints/surveys.
* Administer, direct, and mentor test lab personnel, fostering a high-performance team.
* Ensure the precise maintenance and calibration of quality control instruments, including gages and testing equipment.
* Closely monitor all production processes to ensure strict conformance with product tolerances and specifications.
* Drive organizational focus on reducing the Cost of Poor Quality (COPQ) through targeted initiatives that minimize waste, scrap, and rework.
* Regularly prepare and present detailed reports on program progress, investigation findings, Root Cause Analysis (RCA), and corrective actions to the Division Leadership Team.
What We're Looking For:
* A Bachelor's Degree in a relevant field OR 5-7 years of highly relevant work experience in a quality leadership capacity.
* A minimum of 3-5 years of direct experience in a quality role within a manufacturing or production environment.
* Proven experience successfully leading and mentoring a quality team.
* In-depth knowledge of Quality Management Systems (QMS), quality assurance methodologies, measurement instruments, and quality manufacturing processes.
* Demonstrated experience with Foundry, casting knowledge, manufacturing, or machine shop operations.
* Exceptional data analysis, critical thinking, problem-solving, and statistical skills.
* Must have successfully implemented or maintained ISO 9001 and/or AS9100 standards.
* Proficiency with relevant quality management software and data reporting tools.
* Outstanding written and verbal communication and interpersonal skills.
* Six Sigma certification (e.g., Green or Black Belt) is highly preferred.
What We Offer:
* Medical, dental, and vision insurance for you and your family
* Competitive salary
* Bonus programs
* 401K retirement plan
* Training opportunities
* Tuition reimbursement
* Paid vacation, PTO, and holidays
* Gym reimbursements, and more!
Join us and be a part of a team that values your contributions and supports your goals!
The Dixon Group is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices and laws. Accordingly, to the fullest extent required by applicable law, The Dixon Group strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons. The Dixon Group is committed to protecting the privacy rights of its employees and job applicants to the fullest extent required by applicable law. To that end, personal information will be collected solely for those legitimate business purposes recognized by law, and then maintained in a manner consistent with all applicable laws and regulations pertaining to document retention requirements. The Dixon Group does not sell personal information to third parties, and does not share such personal information with third parties except when authorized by law to do so (e.g., in response to a lawful subpoena; mandatory tax reporting; etc.) Please contact us at ************** or ***************** if you need help to participate fully in the application process.
Easy ApplyQuality Manager
Quality manager job in Landisville, PA
â° Work Hours: ð² Competitive Compensation
Bearon Manufacturing LLC, a proud affiliate of The Dixon Group, is seeking a dynamic and conscientious Manager of Quality Control to lead our quality function in Landisville, PA! This is a critical leadership role that manages both Quality Assurance (QA) and Quality Control (QC) in a busy and growing production environment. If you are a collaborative leader driven by continuous improvement, defect elimination, and risk prevention, you will thrive here. You will partner closely with Manufacturing, Procurement, Engineering, and Customer Service teams to maintain our high standards of excellence.
Who We Are: Bearon Manufacturing LLC is a U.S.-based precision components company with over 40 years of experience. We specialize in machining, casting, prototyping, pattern making and value-added finishing services, operating from a modern facility in Pennsylvania. Our parts serve a wide range of industries including agriculture, emergency equipment, medical, filtration, transportation and ship-building. We're proud of our long-standing commitment to quality, continuous improvement and supporting our customers with industry-leading manufacturing solutions.
At Bearon Manufacturing LLC, we value the contributions of our Military Veterans and proudly employ our nation's heroes. Veterans are strongly encouraged to apply.
âï¸ What You'll Do:
As the Quality Manager, you will be the ultimate owner and driver of quality throughout our entire operation.
Rapidly develop and maintain full ownership of the division's Quality Management System (QMS).
Define and enforce procedures for incoming raw material acceptance, in-process evaluation, and final product inspection and testing.
Ensure QMS compliance by providing comprehensive training to affected personnel and conducting regular internal audits.
Lead the investigation and corrective action process for significant defects, quality notifications, and customer complaints/surveys.
Administer, direct, and mentor test lab personnel, fostering a high-performance team.
Ensure the precise maintenance and calibration of quality control instruments, including gages and testing equipment.
Closely monitor all production processes to ensure strict conformance with product tolerances and specifications.
Drive organizational focus on reducing the Cost of Poor Quality (COPQ) through targeted initiatives that minimize waste, scrap, and rework.
Regularly prepare and present detailed reports on program progress, investigation findings, Root Cause Analysis (RCA), and corrective actions to the Division Leadership Team.
ð¯ What We're Looking For:
A Bachelor's Degree in a relevant field OR 5-7 years of highly relevant work experience in a quality leadership capacity.
A minimum of 3-5 years of direct experience in a quality role within a manufacturing or production environment.
Proven experience successfully leading and mentoring a quality team.
In-depth knowledge of Quality Management Systems (QMS), quality assurance methodologies, measurement instruments, and quality manufacturing processes.
Demonstrated experience with Foundry, casting knowledge, manufacturing, or machine shop operations.
Exceptional data analysis, critical thinking, problem-solving, and statistical skills.
Must have successfully implemented or maintained ISO 9001 and/or AS9100 standards.
Proficiency with relevant quality management software and data reporting tools.
Outstanding written and verbal communication and interpersonal skills.
Six Sigma certification (e.g., Green or Black Belt) is highly preferred.
ð What We Offer:
Medical, dental, and vision insurance for you and your family
Competitive salary
Bonus programs
401K retirement plan
Training opportunities
Tuition reimbursement
Paid vacation, PTO, and holidays
Gym reimbursements, and more!
Join us and be a part of a team that values your contributions and supports your goals!
The Dixon Group is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices and laws. Accordingly, to the fullest extent required by applicable law, The Dixon Group strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered persons. The Dixon Group is committed to protecting the privacy rights of its employees and job applicants to the fullest extent required by applicable law. To that end, personal information will be collected solely for those legitimate business purposes recognized by law, and then maintained in a manner consistent with all applicable laws and regulations pertaining to document retention requirements. The Dixon Group does not sell personal information to third parties, and does not share such personal information with third parties except when authorized by law to do so (e.g., in response to a lawful subpoena; mandatory tax reporting; etc.) Please contact us at ************** or ***************** if you need help to participate fully in the application process.
Easy ApplyQuality Assurance Manager
Quality manager job in Emigsville, PA
Company Statement Graham Packaging is a people, planet and values-based company and a leader in sustainable packaging manufacturing. From the kitchen to the laundry room, Graham Packaging is part of your everyday life. For employees at Graham, our Blue Culture is part of their everyday lives, too. In other words, Blue is how we do things here.
At Graham, we are united by a clear vision. We know our part and help those around us know theirs, encouraging one another to continuously improve. We create a safe, challenging environment to innovate by supporting creative ideas and new ways of thinking. We take the initiative to cultivate our individual growth and help others do the same, while keeping ourselves and one another accountable. And we actively promote cooperation, collaboration, integrity and respect across regions and teams to foster an engaged, diverse and connected workforce.
We value our employees, and a Blue Culture allows for the most rewarding employee experience as part of the Graham family. Blue is how we feel about what we do-together-to create a better tomorrow. Working at Graham means you lead constructively with clear goals, use diverse thinking to drive excellence, accountability, innovation, as well as demonstrating collaboration, embracing learning, and taking action for continuous improvement and growth. Overview
Quality Managers are responsible for the administration and management of all aspects of the plant's quality program for all containers working through the plant quality, production, and logistics personnel. The responsibility includes management of internal / external relationships relative to quality (including supplier, customer, and regulatory compliance), management of internal quality control systems, process critical control points, and quality performance improvement and awareness. As a member of the Plant's management team the Quality Assurance Manager also has shared responsibility for overall Plant operations, especially safety and efficiency. Primary duties of a Quality Manager include:
Understands, follows and enforces all established safety, health, quality GMP and Company policies, procedures and recognized practices.
Understands, follows and enforces all established policies, procedures and recognized practices.
Understand and interpret customer requirements; convert into manufacturing requirements (define necessary inspection and critical process points and required methodologies).
Customer complaint response and tracking: Monitor complaint type and frequency to verify effectiveness of corrective actions.
Define, implement and monitor the systems required to ensure compliance (GMP's, required certifications, sanitation, and customer audit requirements).
Work as required with Engineering, Sales, and Customer Service in completing the above responsibilities.
Work with suppliers as required, defining customer and plant requirements and ensuring conformance.
Assessment and development of operating procedures and controls for all automatic inspection devices.
Define, develop, train, implement and monitor process control points and make necessary improvements for defect elimination.
Regularly communicate customer issues and overall plant quality performance to management, staff, and plant personnel.
Hire, train, and direct the daily activities of the plant quality staff.
Continued evaluation of procedures, in all areas of responsibility for the best practices, particularly in the areas of Safety and efficiency.
May be responsible for special projects related to other functional areas.
0-25% travel may be required.
Qualifications
A Bachelor's Degree and/or related quality experience; or equivalent combination of education and related quality experience is required. A minimum of five years' experience in a quality supervisory or management role in a manufacturing environment with demonstrated leadership skills strongly preferred.
Quality Managers are required to interact with other managers, employees, vendors, and customers. Therefore, the following skills and proficiencies are also essential requirements of the position:
Ability to maintain regular, predictable, and punctual attendance.
Computer usage and typing skills are essential.
Excellent verbal and written communication, including the ability to effectively communicate with internal and external customers.
Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service.
Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
Communicates effectively: conveys facts and information clearly both verbally and orally.
Collaborates well with others: proactively contributes to group objectives; volunteers to help others.
Compensation Statement The expected salary range for the position described in this posting is made in accordance with the legal mandates of certain jurisdictions within the United States. The final agreed-upon compensation is based on individual qualifications and experience. Benefits Statement Benefits include medical, dental, vision and basic life insurance. Employees are able to enroll in the company's 401K Employee Saving Plan and may participate in its Employee Wellness Program. Employees will also receive paid time off in accordance with company policy and state law requirements. EEO Disclaimer Graham Packaging is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex (including pregnancy), sexual orientation, religion, creed, age, national origin, physical or mental disability, gender identity and/or expression, marital status, veteran status or other characteristics protected by law.
Auto-ApplyQuality Assurance Manager
Quality manager job in York, PA
**Company Statement** Graham Packaging is a people, planet and values-based company and a leader in sustainable packaging manufacturing. From the kitchen to the laundry room, Graham Packaging is part of your everyday life. For employees at Graham, our Blue Culture is part of their everyday lives, too. In other words, Blue is how we do things here.
At Graham, we are united by a clear vision. We know our part and help those around us know theirs, encouraging one another to continuously improve. We create a safe, challenging environment to innovate by supporting creative ideas and new ways of thinking. We take the initiative to cultivate our individual growth and help others do the same, while keeping ourselves and one another accountable. And we actively promote cooperation, collaboration, integrity and respect across regions and teams to foster an engaged, diverse and connected workforce.
We value our employees, and a Blue Culture allows for the most rewarding employee experience as part of the Graham family. Blue is how we feel about what we do-together-to create a better tomorrow. Working at Graham means you lead constructively with clear goals, use diverse thinking to drive excellence, accountability, innovation, as well as demonstrating collaboration, embracing learning, and taking action for continuous improvement and growth.
**Overview**
Quality Managers are responsible for the administration and management of all aspects of the plant's quality program for all containers working through the plant quality, production, and logistics personnel. The responsibility includes management of internal / external relationships relative to quality (including supplier, customer, and regulatory compliance), management of internal quality control systems, process critical control points, and quality performance improvement and awareness. As a member of the Plant's management team the Quality Assurance Manager also has shared responsibility for overall Plant operations, especially safety and efficiency. Primary duties of a Quality Manager include:
+ Understands, follows and enforces all established safety, health, quality GMP and Company policies, procedures and recognized practices.
+ Understands, follows and enforces all established policies, procedures and recognized practices.
+ Understand and interpret customer requirements; convert into manufacturing requirements (define necessary inspection and critical process points and required methodologies).
+ Customer complaint response and tracking: Monitor complaint type and frequency to verify effectiveness of corrective actions.
+ Define, implement and monitor the systems required to ensure compliance (GMP's, required certifications, sanitation, and customer audit requirements).
+ Work as required with Engineering, Sales, and Customer Service in completing the above responsibilities.
+ Work with suppliers as required, defining customer and plant requirements and ensuring conformance.
+ Assessment and development of operating procedures and controls for all automatic inspection devices.
+ Define, develop, train, implement and monitor process control points and make necessary improvements for defect elimination.
+ Regularly communicate customer issues and overall plant quality performance to management, staff, and plant personnel.
+ Hire, train, and direct the daily activities of the plant quality staff.
+ Continued evaluation of procedures, in all areas of responsibility for the best practices, particularly in the areas of Safety and efficiency.
+ May be responsible for special projects related to other functional areas.
+ 0-25% travel may be required.
**Qualifications**
A Bachelor's Degree and/or related quality experience; or equivalent combination of education and related quality experience is required. A minimum of five years' experience in a quality supervisory or management role in a manufacturing environment with demonstrated leadership skills strongly preferred.
Quality Managers are required to interact with other managers, employees, vendors, and customers. Therefore, the following skills and proficiencies are also essential requirements of the position:
+ Ability to maintain regular, predictable, and punctual attendance.
+ Computer usage and typing skills are essential.
+ Excellent verbal and written communication, including the ability to effectively communicate with internal and external customers.
+ Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service.
+ Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
+ Communicates effectively: conveys facts and information clearly both verbally and orally.
+ Collaborates well with others: proactively contributes to group objectives; volunteers to help others.
**Compensation Statement**
The expected salary range for the position described in this posting is made in accordance with the legal mandates of certain jurisdictions within the United States. The final agreed-upon compensation is based on individual qualifications and experience.
**Benefits Statement**
Benefits include medical, dental, vision and basic life insurance. Employees are able to enroll in the company's 401K Employee Saving Plan and may participate in its Employee Wellness Program. Employees will also receive paid time off in accordance with company policy and state law requirements.
**EEO Disclaimer**
Graham Packaging is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex (including pregnancy), sexual orientation, religion, creed, age, national origin, physical or mental disability, gender identity and/or expression, marital status, veteran status or other characteristics protected by law.
**Location : Physical Work Location Display Name** _Emigsville, PA_
**ID** _2025-8630_
**Type** _Full-Time_
We believe in equal opportunity for all job candidates, and we do not discriminate on the basis of race, creed, color, ethnicity, national origin, religion, sex, sexual orientation, gender expression, age, physical or mental ability, veteran status, military obligations or marital status. Download these flyers to learn more about our company's policies, including our participation in E-Verify.
QA Manager - Carlisle, PA - Join our Team Today!
Quality manager job in Carlisle, PA
Reporting to the Director of Contract Packaging and Warehouse, the Quality Assurance Manager will ensure all quality standards and current procedures meet or exceed regulations for GMPs as well as the standards set by our Contract Manufacturing clients.
Responsibilities
· Company Culture - exhibits the desired behaviors that support “Our Way” and looks for ways to say “Yes”
· Ensures quality and productivity goals are met on a daily basis
· Manages and leads the activities of the Manufacturing Quality Assurance and Site Sanitation Departments to ensure the highest level of quality.
· Ensures that all manufacturing, packaging, testing, storage and distribution activities are performed in conformance to Customer Specific, FDA, AIB and company policies and/or standard operating procedures.
· Writes, maintains, and self-audits the quality management system to ensure compliance and change management.
· Promotes quality achievement and performance improvement across the organization through the establishment and maintenance of KPIs.
· Maintains a constant awareness of the business context and company profitability.
· Understands and participates in budgeting, manpower planning and forecasting and managing expenditures.
· Maintains the integrity and performance of quality expectations with Lean, cost effective strategies that meet business objectives.
· Responsible for interviewing, hiring, training, development, coaching, disciplining and performance appraisals for employees.
· Ensures workforce is well trained to provide seamless and timely delivery of service.
· Oversees quality investigations for root cause and CAPA determination.
· Accountable for troubleshooting problems through to resolution, escalating as necessary.
· Works closely with all departments to ensure staff are working in compliance with internal policies and procedures, external client expectations and GMPs.
· Hosts regulatory and client audits and assumes responsibility for ensuring that stakeholders are included in proposals for corrective actions.
· Communicates with and responds to Customer inquiries.
· Verifies contractor quality requirements are specified to vendors and contractor documentation submittals.
· Works with Project Managers to develop project schedules and resource allocation models for QA related projects and other activities.
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· Fulfills the duties of a Manager under the Occupational Health and Safety Act, including, safety, violence and harassment laws.
· Manages confidential information/documentation as required by policies.
· Reviews records, reports, documents to comply with Company operational expectations.
· Identifies initiatives to improve team work, morale, cost savings, shift performance and reduced labor cost.
· Assume additional related responsibilities as required.
Education and Experience
· A Bachelor's Degree in Science or Engineering or relevant experience in Food Packaging/Manufacturing.
· Minimum 5+ years' Quality Management Experience.
· 5+ years of experience in Quality Assurance methodologies and policies.
· 5+ years of experience as a manager and strong leadership skills.
· Previous audit experience and/or lead auditor training.
· Working knowledge of applicable GMP and AIB Standards.
· Experience working in a Third Party (3PL) logistics environment.
CORE COMPETENCIES
· Proven track record in driving Continuous Quality Improvement in a manufacturing environment.
· Experience in developing and monitoring Quality Department budgets.
· Comfortable with being directly involved in a fast-paced production environment.
· Proven ability to delegate and follow-up on tasks assigned to Team Members.
· Strong interpersonal and communication skills - both written and verbal with the ability to develop relationships at all levels in the organization.
· Strong organizational, administrative and analytical skills - sound business judgment and a proactive approach to problem solving.
· Goal focused with demonstrated ability to manage multiple tasks/projects in a fast-paced environment with a high attention to detail.
· Able to troubleshoot issues, anticipate problems and make logical decisions.
· Ability to interpret financial spreadsheet information.
· Previous experience with warehouse systems such as Red Prairie and Pack Manager an asset.
· Comfortable working within strict deadlines and under pressure while maintain a professional demeanor.
· Able to lift 50 pounds as necessary from time to time..
· Able to work normal and/or extended (evenings, nights, weekends, holidays) office hours to meet established deadlines.
· Able to travel independently to support Company objectives and personal development.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Auto-ApplyQuality Control Manager
Quality manager job in New Cumberland, PA
JBW Federal is a subsidiary company of the Kanaka Foundation - An NHO who's mission is to support Native Hawaiians.
You will receive a comprehensive benefits package that includes:
Health insurance
Dental insurance
Vision insurance
Pet insurance
Annual membership to Costco or Sam's
401K
...and much, much more!
Job Description: The Quality Control Manager shall be responsible for field execution of assigned projects, including site management, onsite construction operations and oversight of all work being installed for the duration of the Contract. Must have in-depth knowledge and experience as a general contractor for construction including pre-construction planning, scheduling, safety, quality control, equipment and workforce supervision. Must have the ability to lead and problem solve while working with all CSI trade divisions and the assigned self-performing work force.
Responsibilities:
Coordinate daily with Construction Project Manager
Maintain and assist with updating project schedule and three week lookahead
Coordinate subcontractors and support staff to accomplish onsite tasks
Complete daily reporting requirements and catalog site photos
Read/Understand Plans and Specifications
Construct the work according to Plans/Specifications and Contract Documents
Coordinate with Government stakeholders on status of field activities
Monitor workmanship and maintain compliance with submittal requirements
Maintain and Facilitate the Company Safety Program
Review subcontractor materials and workmanship
Facilitate the Company Quality Control Program
Maintain RMS and other Govt reporting programs
Track and complete punch list according to contract requirements
Assist with gathering O&M Manuals and Closeout Documents
Perform other position-related duties as assigned, depending on assignment setting
Minimum Qualifications:
Minimum of 10 years construction experience as a Project Superintendent, Quality Control Manager, Project Manager, Project Engineer or Construction Manager on large, complex, multi-discipline electrical construction Contracts. Must have at least 4 years' experience as a Quality Control Manager.
Familiar with the requirements of EM 385-1-1 and have experience in the areas of hazard identification, safety compliance, and Sustainability
Experience working with RMS (Resident Management System) software
Proficient in Windows operating systems and associated software
Experience working on smartphones and tablets
Ability to work with numerous subcontractors and support staff in an efficient manner
Ability to read Plans, Specifications, and Shop Drawings
Ability to multi-task and establish priorities
Strong communication and analytical skills
CPR/First Aid and OSHA 30 certifications
CQM (Construction Quality Management) Certificate Required
Willing to travel to various job sites
Kanaka Family of Companies is an Equal Opportunity Employer, and all qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, marital status, sex (including pregnancy), gender identity or expression, age, disability, veteran status, sexual orientation, genetic information (family medical history), or any other status protected by federal, state or local laws. EEO/AA employer/Vet/Disabled.
Safety and Quality Coordinator (Electrical Construction)
Quality manager job in York, PA
Job DescriptionSalary:
If you need assistance with the application process, please notify IB Abels Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
About Us
IB Abels 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values Responsible, Integrity, Results-Oriented, Ownership, and Professionalshape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals.
IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System.
The Opportunity
We are seeking a Safety & Quality Coordinator who is responsible for analyzing and developing safety plans, risk assessments, and pre-job briefings; keeping training certifications current; and spending time with field workforce to provide safety and quality leadership for projects related to electrical and utility services.
Key Responsibilities
Safety & Quality Planning and Compliance
-
Review all contract documents to become familiar with project safety and quality requirements and obligations; assure complete and thorough pre-construction planning, as it relates to Safety & Quality, and provide necessary guidance or documentation during preconstruction; facilitate a Site-Specific Safety Plan review with the Project leadership; and attend pre-construction meetings and provide input or any necessary safety and quality responsibilities.
Documentation and Record Management
-
Upload Safety & Quality documents to SharePoint or server for customers, vendors, and subcontractors; and maintain organized and accurate records to support compliance and communication across project teams.
Communication, Coaching and Collaboration
-
Communicate and coach customer safety requirements to ensure understanding and compliance at all project levels; and attend project meetings as needed representing the company on safety and quality matters.
Continuous Improvement and Professional Development
- Stay current on industry standards, regulations, and work practices; and continue education through professional certifications and training.
Who Were Looking For
Electrical Journeyman classification; or Bachelors degree (B.A.) or equivalent from four-year college or technical school as well as 5-years related safety experience and training.
Prior instructor training or experience with instructor certifications preferred.
OSHA 10, 30, 500 training as well as OSHA training and development training.
CSP, CUSP or other related safety certification preferred.
Confined Space Entry Trainer and CPR/First Aid Instructor desirable.
Proficient in MS Office applications with strong skills in Excel, Word, and MS Project.
Local to Pennsylvania (preferable) but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate).
A can-do attitude, strong work ethic, and ability to collaborate effectively with various teams.
Why Choose IBA
Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company.
Flexibility & Autonomy: We empower our team to succeed without micromanagement.
Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision.
Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure.
Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure!
Collaboration: A team environment where we work together to solve challenges and celebrate wins.
Step Into a Career That Powers the Future!
IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.
Quality Manager for Manufacturing Company
Quality manager job in Carlisle, PA
Seeking a Quality Manager in manufacturing company in the Carlisle, PA area.
Essential Skills of the Job:
Lead the Quality Function for the manufacturing company
Develop/build/sustain the QMS system for the plant ensuring the plant is delivering product that meets all established specs
Drive all Quality-related metrics for the plant (Candidate must be a metric-oriented person!)
Provide leadership to Quality Engineers and other staff personnel towards all key quality initiatives
Drive CI efforts for Quality Improvements projects
Be a Chief Problem Solver on all major Internal and External Corrective Actions for the plant
Manage all key quality processes/procedures/policies
Utilize FMEA's
Conduct quality audits daily throughout the plant
Ensure incoming Quality from suppliers is properly measured and proper CA's initiated when necessary
Desired Education, Experience, Qualities:
BS Degree in Engineering or Business preferred. MBA or Master's degree a plus!
Need someone with prior ISO implementation and sustaining experience
Green Belt preferred or higher!
Person must be familiar with all CI tools related to Quality-FMEA's, PPAP's, Six Sigma
Need a Master Problem Solver and someone who has good interaction skills with internal/external customers
Certified Quality Auditor or Certified Quality Engineer a plus
HOT JOB! Please apply in the system below.
Food Safety and Quality Manager
Quality manager job in Womelsdorf, PA
Employee Type:
Full time
Job Type:
Quality
Job Posting Title:
Food Safety and Quality Manager
About Us:
TreeHouse Foods (NYSE: THS) is a leading manufacturer of private label packaged foods and beverages, operating a network of over 20 production facilities and several corporate offices across the United States and Canada. At TreeHouse Foods, our commitment to excellence extends beyond our products and revolves around our people. We are investing in talent and creating a performance-based culture where employees can do their best work and develop their careers, directly impacting our mission to make high quality, affordable food for our customers, communities, and families. We hope you will consider joining the team and being part of our future.
Named one of America's Best Large Employers by Forbes Magazine, we are proud to live by a strong set of values and strive to "Engage and Delight - One Customer at a Time." Guided by our values-Own It, Commit to Excellence, Be Agile, Speak Up, and Better Together. We are a diverse team driven by integrity, accountability, and a commitment to exceptional results. We embrace change, prioritize continuous learning, and foster collaboration, transparency, and healthy debate. Together, we set each other up for success to achieve enterprise-wide goals.
What You Gain:
Competitive compensation and benefits program with no waiting period - you're eligible from your first day!
401(k) program with 5% employer match and 100% vesting as soon as you enroll.
Comprehensive paid time off opportunities, including immediate access to four weeks of vacation, five sick days, parental leave and 11 company holidays (including two floating holidays).
Leaders who are invested in supporting your accelerated career growth, plus paid training, tuition reimbursement and a robust educational platform - DevelopU - with more than 10,000 free courses to support you along the way.
An inclusive working environment where you can build meaningful work relationships with a diverse group of professionals. Take advantage of opportunities to build on our team-oriented culture, such as joining one of our Employee Resource Groups.
Access to our wellness and employee assistance programs.
Job Description:
About the Role:
As the site Food Safety and Quality Manager, you will oversee and ensure the implementation of Quality Assurance (QA) programs for the Womelsdorf, PA site, a manufacturer of confections. This role upholds product quality, food safety, and sanitation in compliance with company standards and regulatory requirements.
You'll add value to this role by performing various functions including, but not limited to:
Oversee, implement, and maintain QA programs, including Formula Control, Allergen Control, Non-Conforming Products, Recalls, Food Safety Plans, and pest control systems.
Develop, implement, and manage comprehensive sanitation programs for daily and periodic cleaning of the facility.
Define and enforce best laboratory practices and quality policies.
Ensure compliance with company, state, and federal sanitation regulations.
Collaborate with R&D to improve product quality and cost-effectiveness, support product changes, and oversee plant testing.
Coach, mentor, and develop quality and sanitation leaders/supervisors in addition to providing quality and food safety training for employees at all levels.
Conduct quality and sanitation audits and summarize technical data to identify trends and corrective actions as well as, support quality systems and initiatives.
Serve as the plant's liaison for regulatory authorities, including USDA, FDA, and third-party auditors.
Important Details:
This is a full-time, on-site role on our first shift. Occasional flexibility is required to support alternate shifts.
You'll fit right in if you have:
Bachelor's degree in food science, Biology, or a related field. SQF Practitioner certification and Food Defense Program leadership experience preferred.
Minimum of 5 years of supervisory experience in a food manufacturing environment.
In-depth knowledge of sanitation practices, GMPs, FDA/USDA regulations, and third-party audits.
Hands-on experience with GFSI certification, CFR expectations, pre-operational inspections, and SPC systems.
Demonstrated problem solving, leadership, and analytical skills.
Experience in creating, executing, and monitoring manufacturing technical standards and procedures.
Experience using Microsoft Office.
Your TreeHouse Foods Career is Just a Click Away!
Click on the “Apply” button or go directly to ****************************** to let us know you're ready to join our team!
At TreeHouse Foods, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work to help us “Engage and Delight - One Customer at a Time”. TreeHouse Foods is an Equal Opportunity Employer that prohibits discrimination or harassment of any type. All qualified applicants are considered for employment without regard to race, color, national origin, age, sex, sexual orientation, gender, gender identity or expression, disability status, protected veteran status, or any other characteristic protected by law. Applicants who require an accommodation to participate in the job application or hiring process should contact disability-accommodations@treehousefoods.com
TreeHouse Use Only: #IND1
Auto-ApplyBakery Quality Manager
Quality manager job in Denver, PA
Since 1869 we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Michael Angelo's, Pace, Pacific Foods, Prego, Rao's Homemade, Swanson, and V8. In our Snacks division, we have brands like Cape Cod, Goldfish, Kettle Brand, Lance, Late July, Pepperidge Farm, Snack Factory, and Snyder's of Hanover. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our "Campbell's Cares" program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees.
How you will make history here…
The Bakery Quality Manager has specific compliance, process, and consumer quality responsibilities for the Bakery business unit and compliance / audit readiness for the site. This position will manage a matrix relationship with the Senior Quality Manager and Plant Manager to in‐fluence senior management on alignment of Quality strategies, Quality annual objectives, and project plans. Individual will coordinate and deploy Quality Assurance programs and influence plant leadership with quality best practices.
What you will do…
Principal Accountabilities:
* 30% - Develop, drive, and continually improve a comprehensive quality program as defined by the Campbell's Snack QPM and CSC North American Quality Policies. (Compliance Quality)
* 20% - Drive process improvement initiatives through staff, workgroup, Campbell's Snack Quality staff, and R&D (Process/Food Quality)
* 20% - Lead site compliance and audit readiness for all BUs (Cookies, Crackers, Bakery)
* 15% - Manage team by establishing goals, objectives, individual development plans and coaching.
* 10% - Manage & Drive Consumer Complaint programs, initiatives, and consumer delight models.
* 5% - Support programs across Safety, People, Quality, Delivery and Cost.
Job Complexity / Scope:
* Response to new or changes in regulations on specifications, procedures, quality, and implications utilized in a range of finished product.
* Troubleshooting quality issues across the varied supply chains for ingredients, packaging, materials, and finished products supplied (examples; mixed labels, allergen risk management, equipment risk management, container nonconformance).
* Expert abilities and decision quality in Food Safety, Regulatory, and Quality Systems and their application within food processing. Facilitate and/or direct resolution to issues as it relates to food safety and quality.
* Expert knowledge in Sanitation and GMP Practices, familiarity with Pest Control programs and techniques
* Knowledge of Quality Standards, and Quality Policies, with skills and ability to execute against requirements.
* Knowledge and general business acumen to support and influence Manufacturing, including best practices and innovative technologies.
* Knowledgeable in industry Food Safety/Quality audit practices, and skilled in adapting to achieve business best practices.
* Capable of engaging other business units in the development and standardization of: Quality manuals, policies, procedures, and data templates, audit standards and procedures, and Quality Key Performance Indicators.
* Knowledgeable in Statistical Process Control programs and Process capability studies.
* Ensures personnel are technically capable of handling non-routine quality system issues and that issues are investigated, documented, and resolved.
* Record of leadership and demonstrated success in collaborative development, documentation, planning, and implementation and continuous improvement of quality systems.
* Ability to drive organizational alignment on Quality objectives with an enterprise-wide mindset, and the adaptation of structure, processes, and systems to achieve objectives.
* Capable of influencing development steps used in the Innovation and Commercialization process to leverage Design in achieving consumer safety and quality objectives.
* Assertive, outspoken, yet collaborative. Demonstrated skills influencing components of the business, tough-mindedness, vision, and political savvy to manage internal and external relationships and situations.
* Dedicated work habits, takes initiative, sets high standards Knowledgeable and capable of collaboration on quality pro‐ grams; drives improvement of consumer-based specifications. Aware of Continuous Improvement tools.
* Ability to manage, coach, and develop people, talent, and skills needed for the job.
* Ability to demonstrate and execute against the Campbell leadership model behaviors of Inspire Trust, Create Direction, Drive Decision Making, Build Talent & Culture, execute with Excellence, and Own the Results.
Who you will work with…
You will work with the Quality, Sanitation and other teams in the bakery business unit in the plant.
What you bring to the table (must haves) …
* Bachelor's degree, preferably in Food Science or related
* 4 years' experience in food industry quality plant / systems experience with demonstrated achievement in Quality Leadership
It would be great to have (nice to haves)…
* PCQI (Preventive Control Qualified Individual), HACCP (Hazard Analysis Critical Control Point) certified, SQF (Safe Quality Foods) certified strongly preferred
* Up to 10 % travel.
Compensation and Benefits: The target base salary range for this full-time, salaried position is between
$85,200-$122,500
Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package.
The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.
Auto-ApplyQA Manager - Carlisle, PA - Join our Team Today!
Quality manager job in Carlisle, PA
Job Description
Reporting to the Director of Contract Packaging and Warehouse, the Quality Assurance Manager will ensure all quality standards and current procedures meet or exceed regulations for GMPs as well as the standards set by our Contract Manufacturing clients.
Responsibilities
· Company Culture - exhibits the desired behaviors that support “Our Way” and looks for ways to say “Yes”
· Ensures quality and productivity goals are met on a daily basis
· Manages and leads the activities of the Manufacturing Quality Assurance and Site Sanitation Departments to ensure the highest level of quality.
· Ensures that all manufacturing, packaging, testing, storage and distribution activities are performed in conformance to Customer Specific, FDA, AIB and company policies and/or standard operating procedures.
· Writes, maintains, and self-audits the quality management system to ensure compliance and change management.
· Promotes quality achievement and performance improvement across the organization through the establishment and maintenance of KPIs.
· Maintains a constant awareness of the business context and company profitability.
· Understands and participates in budgeting, manpower planning and forecasting and managing expenditures.
· Maintains the integrity and performance of quality expectations with Lean, cost effective strategies that meet business objectives.
· Responsible for interviewing, hiring, training, development, coaching, disciplining and performance appraisals for employees.
· Ensures workforce is well trained to provide seamless and timely delivery of service.
· Oversees quality investigations for root cause and CAPA determination.
· Accountable for troubleshooting problems through to resolution, escalating as necessary.
· Works closely with all departments to ensure staff are working in compliance with internal policies and procedures, external client expectations and GMPs.
· Hosts regulatory and client audits and assumes responsibility for ensuring that stakeholders are included in proposals for corrective actions.
· Communicates with and responds to Customer inquiries.
· Verifies contractor quality requirements are specified to vendors and contractor documentation submittals.
· Works with Project Managers to develop project schedules and resource allocation models for QA related projects and other activities.
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· Fulfills the duties of a Manager under the Occupational Health and Safety Act, including, safety, violence and harassment laws.
· Manages confidential information/documentation as required by policies.
· Reviews records, reports, documents to comply with Company operational expectations.
· Identifies initiatives to improve team work, morale, cost savings, shift performance and reduced labor cost.
· Assume additional related responsibilities as required.
Education and Experience
· A Bachelor's Degree in Science or Engineering or relevant experience in Food Packaging/Manufacturing.
· Minimum 5+ years' Quality Management Experience.
· 5+ years of experience in Quality Assurance methodologies and policies.
· 5+ years of experience as a manager and strong leadership skills.
· Previous audit experience and/or lead auditor training.
· Working knowledge of applicable GMP and AIB Standards.
· Experience working in a Third Party (3PL) logistics environment.
CORE COMPETENCIES
· Proven track record in driving Continuous Quality Improvement in a manufacturing environment.
· Experience in developing and monitoring Quality Department budgets.
· Comfortable with being directly involved in a fast-paced production environment.
· Proven ability to delegate and follow-up on tasks assigned to Team Members.
· Strong interpersonal and communication skills - both written and verbal with the ability to develop relationships at all levels in the organization.
· Strong organizational, administrative and analytical skills - sound business judgment and a proactive approach to problem solving.
· Goal focused with demonstrated ability to manage multiple tasks/projects in a fast-paced environment with a high attention to detail.
· Able to troubleshoot issues, anticipate problems and make logical decisions.
· Ability to interpret financial spreadsheet information.
· Previous experience with warehouse systems such as Red Prairie and Pack Manager an asset.
· Comfortable working within strict deadlines and under pressure while maintain a professional demeanor.
· Able to lift 50 pounds as necessary from time to time..
· Able to work normal and/or extended (evenings, nights, weekends, holidays) office hours to meet established deadlines.
· Able to travel independently to support Company objectives and personal development.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Safety and Quality Coordinator (Electrical Construction)
Quality manager job in York, PA
If you need assistance with the application process, please notify IB Abel's Human Resources Department. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
About Us
IB Abel's 110-year history is a testament to its adaptability, forward-thinking leadership, commitment to safety, and stellar service and project delivery process. Our core values-Responsible, Integrity, Results-Oriented, Ownership, and Professional-shape everything that we do at all levels of the company and are purposefully incorporated into all company communications, meetings, and strategic planning. Our use of the EOS model (Entrepreneurial Operating System) also provides structure and clarity among all levels of the company to maintain focus on our shared goals.
IB Abel (IBA) is committed to providing ample learning and career development opportunities to its team members via our Associate's Program in Project Management, Estimating, and Accounting and our growing Learning Management System.
The Opportunity
We are seeking a Safety & Quality Coordinator who is responsible for analyzing and developing safety plans, risk assessments, and pre-job briefings; keeping training certifications current; and spending time with field workforce to provide safety and quality leadership for projects related to electrical and utility services.
Key Responsibilities
Safety & Quality Planning and Compliance
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Review all contract documents to become familiar with project safety and quality requirements and obligations; assure complete and thorough pre-construction planning, as it relates to Safety & Quality, and provide necessary guidance or documentation during preconstruction; facilitate a Site-Specific Safety Plan review with the Project leadership; and attend pre-construction meetings and provide input or any necessary safety and quality responsibilities.
Documentation and Record Management
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Upload Safety & Quality documents to SharePoint or server for customers, vendors, and subcontractors; and maintain organized and accurate records to support compliance and communication across project teams.
Communication, Coaching and Collaboration
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Communicate and coach customer safety requirements to ensure understanding and compliance at all project levels; and attend project meetings as needed representing the company on safety and quality matters.
Continuous Improvement and Professional Development
- Stay current on industry standards, regulations, and work practices; and continue education through professional certifications and training.
Who We're Looking For
Electrical Journeyman classification; or Bachelor's degree (B.A.) or equivalent from four-year college or technical school as well as 5-years related safety experience and training.
Prior instructor training or experience with instructor certifications preferred.
OSHA 10, 30, 500 training as well as OSHA training and development training.
CSP, CUSP or other related safety certification preferred.
Confined Space Entry Trainer and CPR/First Aid Instructor desirable.
Proficient in MS Office applications with strong skills in Excel, Word, and MS Project.
Local to Pennsylvania (preferable) but with regular travel to other offices, customer facilities, jobsites and yard locations for offsite meetings (flexibility to work from home when appropriate).
A “can-do” attitude, strong work ethic, and ability to collaborate effectively with various teams.
Why Choose IBA
Culture of Growth: Many of our leaders started in entry-level field roles and advanced within the company.
Flexibility & Autonomy: We empower our team to succeed without micromanagement.
Competitive Compensation & Benefits: Includes competitive salary, vehicle allowance program, 401(k) with company matching, tuition reimbursement, and comprehensive benefits package including medical, dental, and vision.
Stability & Variety: Work for multi-generational family-oriented business on diverse, fast-paced projects without the stress of a large corporate structure.
Incentives: Performance-based bonuses/incentives and a progressive PTO programs that grows with your tenure!
Collaboration: A team environment where we work together to solve challenges and celebrate wins.
Step Into a Career That Powers the Future!
IB Abel is an equal opportunity employer, all qualified applicants are encouraged to apply.
Quality Manager for Manufacturing Company
Quality manager job in Carlisle, PA
Seeking a Quality Manager in manufacturing company in the Carlisle, PA area.
Essential Skills of the Job:
Lead the Quality Function for the manufacturing company
Develop/build/sustain the QMS system for the plant ensuring the plant is delivering product that meets all established specs
Drive all Quality-related metrics for the plant (Candidate must be a metric-oriented person!)
Provide leadership to Quality Engineers and other staff personnel towards all key quality initiatives
Drive CI efforts for Quality Improvements projects
Be a Chief Problem Solver on all major Internal and External Corrective Actions for the plant
Manage all key quality processes/procedures/policies
Utilize FMEA's
Conduct quality audits daily throughout the plant
Ensure incoming Quality from suppliers is properly measured and proper CA's initiated when necessary
Desired Education, Experience, Qualities:
BS Degree in Engineering or Business preferred. MBA or Master's degree a plus!
Need someone with prior ISO implementation and sustaining experience
Green Belt preferred or higher!
Person must be familiar with all CI tools related to Quality-FMEA's, PPAP's, Six Sigma
Need a Master Problem Solver and someone who has good interaction skills with internal/external customers
Certified Quality Auditor or Certified Quality Engineer a plus
HOT JOB! Please apply in the system below.
Manager, Global Product Quality - Controlled Substances
Quality manager job in Harrisburg, PA
The Manager, Global Product Quality - Controlled Substances is responsible for ensuring that all activities related to controlled substances across the product lifecycle meet Good Manufacturing Practices (GMP) and comply with global regulatory requirements, including DEA regulations. This role partners closely with R&D, Supply Chain, Product Development, and Warehousing & Distribution teams to ensure robust quality oversight and regulatory compliance in the handling, storage, manufacturing, and distribution of controlled substances.
The role may also support day to day quality oversight of clinical and commercial products to ensure they are manufactured, tested, packaged, stored and distributed in compliance with Current Good Manufacturing Practices (CGMP) regulations, Otsuka Quality Standards and US/global (if applicable) regulatory requirements.
**Key Responsibilities**
+ Product Oversight: Provide GMP oversight and guidance during the drug development process including review and approval of documentation and collaboration and oversight of suppliers/contract manufacturers.Act as a liaison with regulatory agencies and internal compliance teams regarding controlled substance matters.
+ Quality & Compliance:Serve as the quality and compliance lead for controlled substances, ensuring adherence to DEA regulations and other global controlled substance requirements (e.g., Health Canada, EMA, ANVISA). Develop, implement, and maintain global SOPs and standards for the compliant handling, storage, transportation, and distribution of controlled substances. Ensure warehousing and distribution operations meet all applicable regulatory and internal quality requirements, including security, inventory reconciliation, and chain-of-custody controls.
+ Audit & Inspection Readiness: Support DEA inspections, audits, and regulatory submissions, ensuring readiness and robust documentation. Participates in regulatory inspections and audits as required.
+ Process Optimization: Oversee and enhance quality systems related to product quality complaints, CAPA, deviations, and change control for controlled substances.
+ Data Analysis & Reporting: Monitor and analyze compliance metrics and trends to identify risks and drive continuous improvement initiatives.
+ Cross-functional Collaboration: Collaborate with R&D, Supply Chain, Product Development, and Manufacturing to ensure quality and compliance are integrated throughout the lifecycle of controlled substance products.
+ Training & Documentation: Provide training and guidance to global teams on controlled substance regulations, GMP expectations, and best practices. Authors and maintains SOPs, Work practices and Job Aids, related to assigned quality activities.
**Qualifications**
Required
+ Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related field.
+ Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3-5 years in pharmaceutical quality, with specific experience in controlled substances and commercial quality operations.
+ Demonstrated expertise in DEA regulations and compliance, including registration, quota management, recordkeeping, and reporting.
+ Working knowledge and understanding of FDA/ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and Part 11 (and Part 820, if applicable), ICH Q7
+ Strong understanding of GMP requirements and global regulatory expectations for controlled substances.
+ Experience managing quality systems (e.g., deviations, CAPA, change control, complaints) in a regulated environment.
+ Proven experience in warehousing and distribution controls, including security, inventory management, and transportation compliance for controlled substances.
+ Excellent communication, collaboration, and project management skills.
+ Must be detail oriented and able to write and/or review Technical Documents
+ Ability to work effectively in a global, cross-functional, and matrixed environment
Preferred Experience
+ Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, or similar.
+ Certification in DEA compliance, Quality Assurance, or Regulatory Affairs.
**Disclaimer**
This is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.