Quality assurance specialist jobs in Burlington, NC - 228 jobs
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Senior Quality Assurance Manager
Quality Assurance Specialist
Planet Pharma 4.1
Quality assurance specialist job in Holly Springs, NC
100% ONSITE
1 year contract
This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects.
• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
• Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
• Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
• Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
• Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
• Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
o May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders.
• Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
• Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
• Participate in meetings related to document planning, execution, and issue resolution.
• Escalate any compliance concerns or critical gaps to QA management.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
$52k-85k yearly est. 5d ago
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QA/QC Technician - Electrical Construction
Kodiak Construction Recruiting & Staffing
Quality assurance specialist job in Greensboro, NC
Location: Greensboro, NC | Full-Time
Who We Are
We are a trusted leader in the electrical construction industry, known for nearly a century of craftsmanship, safety, and integrity. Headquartered in Greensboro, NC, we've built a reputation for delivering complex, high-quality electrical projects across the Southeast with precision, innovation, and teamwork.
Our culture emphasizes collaboration, mentorship, and continuous learning, creating an environment where talented professionals grow their careers while taking pride in the work they do every day.
Position Summary
We're seeking a QA/QC Technician to support project quality and performance through on-site inspections, documentation, and team coordination. This position plays a critical role in maintaining the company's high standards of consistency, accuracy, and safety.
The ideal candidate has hands-on experience in electrical construction, a keen eye for detail, and the ability to communicate effectively across teams and job sites.
What You'll Do
Conduct field inspections of underground systems, temporary power, switchgear, and equipment installations
Review project scopes and QA/QC expectations during kickoff meetings
Collaborate with field teams, general contractors, and project managers to ensure compliance with company and client standards
Use the QuickBase QA/QC App to record inspections, document issues, and manage nonconformance reports
Verify torque and megger testing results and closeout documentation accuracy
Promote best practices and consistency across projects
Support administrative and documentation tasks as needed
Travel to job sites, including occasional out-of-town projects
What We're Looking For
5+ years of experience in electrical construction (Foreman or Superintendent experience preferred)
Strong knowledge of electrical systems, QA/QC standards, and installation practices
Proficient in Microsoft Office Suite and the QuickBase QA/QC App
Excellent communication, organization, and reporting skills
Comfortable performing physical inspections in active construction environments
Dedicated to safety, quality, and teamwork
Why You'll Love Working Here
A company built on integrity, safety, and technical excellence
Collaborative, mentorship-driven culture with advancement opportunities
Work on diverse, high-profile projects across multiple industries
Competitive pay, benefits, and ongoing professional training
If you're ready to join a respected team that values craftsmanship, accountability, and innovation - apply today and help us build what lasts.
$26k-41k yearly est. 3d ago
Senior Quality Assurance Associate
Infotree Global Solutions 4.1
Quality assurance specialist job in Holly Springs, NC
Note:
Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule.
Must have: Manufacturing and PQA background
Let's do this. Let's change the world. Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance
Responsibilities:
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
Oversee and provide guidance during on-the-floor analytical testing.
Ensure that changes that could potentially impact product quality are assessed according to procedures.
Ensure that deviations from established procedures are investigated and documented per procedures.
Alert senior management of quality, compliance, supply and safety risks.
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
Identification and implementation of continuous improvement opportunities within our processes and systems.
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Basic Qualifications
High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
Top 3 Must Have Skill Sets:
Previous work on GMP Facilities
PQA or Mfg preferably Drug Substance Experience
Previous work with Batch records/Deviations/QA Oversight
Nice to have: B.S. degree
Day to Day Responsibilities:
On the floor guidance/Mfg support
Oversee compliance in execution
Batch Record Review
SOP review/Approvals
Deviation Review
Help Mfg Problem solve with Quality mindset
$62k-79k yearly est. 5d ago
Senior Quality Assurance Associate
Spectraforce 4.5
Quality assurance specialist job in Holly Springs, NC
Job Title: Quality Assurance Senior Associate
Duration: 12 Months
Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule.
Must have: Manufacturing and PQA background
Summary:
Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance
Responsibilities:
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Requirements:
Previous work on GNP Facilities
PQA or Mfg preferably Drug Substance Experience
Previous work with Batch records/Deviations/Qa Oversight
Nice to have: B.S. degree
$68k-87k yearly est. 4d ago
Quality Assurance Operations Manager
Boston Analytical 4.2
Quality assurance specialist job in Morrisville, NC
Job DescriptionSalary:
The Quality Assurance Operations Manager supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports).
PRIMARY DUTIES AND RESPONSIBILITIES
Provide direct oversight to QA operations staff.
Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.
Review, approve Laboratory test data and reports.
Prepare and approve certificates of Analysis.
Support activities related to internal and external audits.
Represent site Quality group during Client and regulatory audits.
Collaborate with Laboratory management to support company goals.
Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness.
Actively participate in operational excellence programs/initiatives.
Review laboratory protocols and reports for accuracy and compliance to cGMPs, as applicable.
Site system owner for OOS, complaint, and deviation programs.
Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation.
Completes required actions for identified corrective/preventive actions for the Quality department.
REQUIREMENTS & QUALIFICATIONS
Qualification include a Bachelors degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development.
DESIRED SKILLS
Enthusiastic, team player, collaborative across all departments to achieve the common goals.
Ability to focus on internal processes while maintaining focus on client needs.
Ability to work in a fast paced, dynamic environment.
Experience with LEAN implementation.
Familiarity with laboratory information management systems.
ISO 17025 or 9001 experience and knowledge.
Demonstrated ability to foster a Quality Culture across the organization.
Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.
$73k-105k yearly est. 4d ago
QA Specialist II
KBI Biopharma Inc. 4.4
Quality assurance specialist job in Durham, NC
is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- is also responsible for the review and
approval of method qualifications and validations. Another responsibility is the
review and approval of laboratory investigations and deviations associated with the
biopharmaceutical development department.
JOB RESPONSIBILITIES:
Performs compliance review on the following records: release, in-process, and stability data.
Responsible for the review and approval of method qualifications and validations
Responsible for the review and approval of deviations and laboratory investigations.
MINIMUM REQUIREMENTS:
BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated
environment within biopharmaceuticals or equivalent.
Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and
deviations. Knowledge of USP, EU and JP cGMP guidelines.
Ability to read, analyze, and interpret general business periodicals, professional journals,
technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to solve practical problems and deal with a variety of concrete variables in
situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Basic math skills are required.
Ability to apply concepts of basic algebra and statistics.
Be able to sit for long periods of time.
Ability to lift 20 pounds.
Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
$75k-107k yearly est. Auto-Apply 60d+ ago
Specialist Quality Assurance
Us Tech Solutions 4.4
Quality assurance specialist job in Holly Springs, NC
This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem at and ongoing Automation support to the Manufacturing floor and expansion projects.
**Key Responsibilities:**
+ Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
+ Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
+ Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
+ Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
+ Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
+ Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
+ May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders.
+ Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
+ Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
+ Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
+ Participate in meetings related to document planning, execution, and issue resolution.
+ Escalate any compliance concerns or critical gaps to QA management.
+ In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master degree and 3 years of experience OR
+ Bachelor degree and 5 years of experience OR
+ Associate degree and 10 years of experience OR
+ High school diploma / GED and 12 years of experience
**Must Have Skill Sets:**
+ Previous experience in computer system validation (CSV) or quality oversite of CSV.
+ Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired.
+ Experience with computerized systems including troubleshooting, reliability, and performance improvements.
**Day to Day Responsibilities:**
+ Will work with an established QAV team to support automation and DTI for the site and expansion projects.
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** .
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
$53k-96k yearly est. 7d ago
Specialist, Quality Assurance
LCI Brand 4.8
Quality assurance specialist job in Durham, NC
ABOUT LCI
The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways:
EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives.
BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels.
SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military.
SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired.
ABOUT THIS ROLE
The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products.
LOCATION AND SCHEDULE
Durham, NC
Monday-Friday 7 AM - 3:30 PM
KEY RESPONSIBILITIES
Batch Review and disposition:
Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches.
Review and approve Master Batch Records.
Perform the review of records and determine disposition of:
Medical Devices
Packaged/Labeled Medical Devices
Clinical Product
Investigations and CAPAs.
Perform the review of Testing Specifications.
Validation
Coordinate and monitor validation activities.
Provide support during regulatory inspections of GMP Contractors and LCI facilities.
Assist in performing inspection readiness activities.
Review Quality Agreements.
Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry.
Provide updates to Manager, BioMed Operations.
QUALIFICATIONS
Bachelor's Degree in a life science-related discipline or equivalent work experience.
Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation.
Experience in working with third-party contract manufacturers, laboratories, and packagers.
Knowledge of pharmaceutical industry regulatory requirements.
High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions.
Ability to exercise strong risk-based business judgment.
Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization.
Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality.
Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally
Good investigation and monitoring skills.
Current knowledge of QC testing methods.
Attention to detail and implementation of good documentation and GMP processes is essential.
Excellent communication skills required and must be computer literate.
Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations.
Why LCI?
Purpose-driven company driven by principles, not profit
Reach your highest potential: upward mobility, rewarded through hard work
Competitive salary and compensation
Basic Life Insurance at no cost to the employee
401(k) with match and Surplus-Sharing Plans
Health, Dental, and Vision Insurance
Ten paid holidays annually
Paid Time Off (PTO)
On-site Health and Wellness program
Employee Assistance Program (EAP)
$57k-93k yearly est. 60d+ ago
Technical Documentation Specialist
Lancesoft 4.5
Quality assurance specialist job in Greensboro, NC
Technical Documentation Specialist in Greensboro NC Duration: 3 months contract with possible extension Job Description: Organizing an archiving system.-Labeling, sorting, and categorizing documents for ease of use.-Retrieving documents upon request.-Outlining a long-term storage strategy.-Adhering to regulatory requirements.-Working with colleagues to ensure consistency of documentation practice across the company.-Assisting with both internal and external audits.-Ensuring documentation integrity.-Controlling access to documents.-Removing documents that are obsolete.-Utilizing storage software and applications for electronic filing.-Performing transcription and conversion work.-Proofreading documents upon request.
1. Execute with Excellence - Previous role experience within Initiative Leadership, Project Management, Marketing Specialist, or Work Process Ownership. Demonstration and Implementation of work processes, workflows, working with Multifunctional Resources/Teams. Acts as a business owner with great sense of urgency and focus to manage multiple projects/priorities with the organization and attention to detail. High Capacity to lead multiple projects at any given period.
2. Lead with Courage -Ability to demonstrate Leadership to set direction/priority for others, hold others accountable to deadlines, develop execution plans, and work collectively across functions and suppliers. Can manage expectations and engagement across all business functions.
3. Embraces Change -Is open and flexible/adaptable to change by seeking out and readily accepting new ideas, experiences, skills, opportunities, and new work processes.
4. Excellent Communications/Collaboration skills to lead meetings, listening to feedback/input to put into clear actions, written updates to Initiative teams/leadership, peers and escalate help requests/issues. Strong Collaboration with internal and external partners.
5. Strong Problem-solving skills to quickly identify and resolve issues to root cause, access risk and determine approach/next steps to mitigate.
6. Champion Productivity- Demonstration of skills/experience to analyze data for utilization in results reporting (written/oral), gap analysis, loss analysis and work process improvement. Is capable to demonstrate mastery within Microsoft Word, Excel, Powerpoint and Office 365 Tools. Skills Needed: Leadership, Embraces Change/Agile, Collaborative, Develops Others, Operates with Discipline, Business Mastery, Technical Mastery.
Must have:
Accurate documentation skills
GMP (Good Manufacturing Practices) Compliance
GDP (Good Documentation Practices)
QMS (Quality Management Systems)
FDA 21 CFR Part 210, 211, 820 Regulations, Batch Record Review & Approval, CAPA (Corrective and Preventive Actions) •Investigation & Deviation Management, Change Control Management, Quality Systems Auditing (Internal/External)
Pre-Approval Inspection (PAI) Preparedness, Aseptic Processing & Sterile Drug Products
Document Control & SOP Review
Training Program Development & Delivery
On-the-Job Training (OJT) & Curriculum Development
Regulatory Compliance & Inspection Readiness, Data Integrity & LIMS
Root Cause Analysis & Problem Solving, Customer Complaint Investigation
Project Management & Continuous Improvement
TrackWise, Veeva Vault, Documentum, QUMAS •MS Visio, MS PowerPoint, Excel, Word, Smartsheet
Nice to have: Previous experience in Enovia and Veeva systems highly desired
$66k-109k yearly est. 44d ago
Plan Document Specialist
Ascensus 4.3
Quality assurance specialist job in Greensboro, NC
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch personalized service from local TPAs backed by the strength and security of a large national firm, Ascensus. Our roots go back decades, with nearly 30 outstanding legacy firms now joined together to deliver unmatched levels of service, innovation and expertise to a fast-growing client base from coast to coast. The FuturePlan team includes more than 500 credentialed plan professionals, 60 actuaries, and one of the industry's largest in-house ERISA teams. Learn more at FuturePlan.com.
Section 1: Position Summary
* Responsible for the following tasks related to basic to medium complexity retirement plans:
* Draft plan document including new plan documents and plan restatements
* Draft plan amendments
* Prepare/update Summary of Plan Description and other related documents
* Prepare IRS submissions
* Prepare plan termination documents and submissions
* Prepare annual notices
* Perform technical research to answer compliance questions or resolve compliance issues
* Work with Relationship Consultant to ensure signed documents are accurate and received timely
* Complete assigned projects timely, accurately and in a cost effectively manner
* Proactively participate in process improvement and innovation of current systems
* Ensure client plan document files and records are organized and up to date
* Commitment to ongoing pension education along with staying current with regulations and law changes
* Enter consulting time in timekeeping system daily
* Update workflow system daily
* Perform Special projects
* Other duties as assigned
Section 3: Experience, Skills, Knowledge Requirements
SKILLS NEEDED
* Excellent verbal and written communication skills, including the ability to communicate technical ideas
* Must possess strong organizational skills
* Must have knowledge of a variety of computer software applications in word processing, spreadsheets and database software
* Self-starter who will take responsibility for completing tasks in a timely fashion
* Work requires continual attention to detail in reviewing materials, managing multiple projects, establishing priorities and meeting deadlines
* Dependable with excellent follow through on commitments and responsibilities
* Conceptual and analytical
* Ability to work in a team environment and also work independently as appropriate
* Ability to work in fast paced, ever changing office environment
* Must be willing to maintain a flexible work schedule and work overtime as needed
EXPERIENCE NEEDED
* A minimum of 2 years of retirement plan administration experience or equivalent preferred
TRAVEL REQUIREMENTS
* None
PHYSICAL DEMANDS
* Must be able to sit for long periods (at least 8 hours per day).
* Must be able to work on a computer at least 8 hours per day (includes looking at a monitor, and typing using a keyboard and mouse).
EDUCATION/TRAINING NEEDED
* B.A. or B.S. degree preferred
* ASPPA designation or actuarial exams preferred
We are proud to be an equal opportunity employer.
Be aware of employment fraud. All email communications from Ascensus or its hiring managers originate ****************** ****************** email addresses. We will never ask you for payment or require you to purchase any equipment. If you are suspicious or unsure about validity of a job posting, we strongly encourage you to apply directly through our website.
For all virtual remote positions, in order to ensure associates can effectively perform their job duties with no distractions, we require an uninterrupted virtual work space and there is also an expectation of family care being in place during business hours. Additionally, there is an internet work speed requirement of 25 MBps or better for individual use. If more than one person is utilizing the same internet connection in the same household or building, then a stronger connection is required. If you are unsure of your internet speed, please check with your service provider. Note: For call center roles specifically, it is a requirement to either hardwire your equipment directly to the internet router or ensure your workstation is in close proximity to the router. Please ensure that you are able to meet these expectations before applying.
Ascensus provides equal employment opportunities to all associates and applicants for employment without regard to ancestry, race, color, religion, sex, (including pregnancy, childbirth, breastfeeding and/or related medical conditions), gender, gender identity, gender expression, national origin, age, physical or mental disability, medical condition (including cancer and genetic characteristics), marital status, military or veteran status, genetic information, sexual orientation, criminal conviction record or any other protected category in accordance with applicable federal, state, or local laws ("Protected Status").
$44k-72k yearly est. 5d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Greensboro, NC
At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.
JOB DESCRIPTION
Count on Me - We know what to do, we make it easy, we do our part and we care!
Job Title: FT/PT Quality Assurance Associate
Success Factors Job Code: 1300594
Department: Center Store (Grocery)
Reports To: Assistant Store Manager
Where Applicable: Evening Manager
Primary Purpose:
Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.
Duties and Responsibilities:
Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
Courteous and helpful to other associates
Sweep and clean floors on nights with no scheduled vendor services
Weekly cleaning of Produce, Market and Deli Departments
Clean and organize the store mop room
Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
Follow QA daily check list and sanitation standards set by Food Lion
Follow current Standard Practices regarding cleanup of Hazardous Waste product
Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
Understand and follow Food Safety and Workplace Safety guidelines and procedures
Observe and correct all unsafe conditions that could cause associate or customer accidents
Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
Ensure compliance with local, state and federal regulations
Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
Perform all other duties as assigned
Qualifications:
High school graduate or equivalent preferred
Excellent interpersonal, organizational, communication and customer service skills
Ability and willingness to learn multiple tasks and technical requirements of the job
Ability to use technical information to solve problems
Must meet minimum age requirements to perform specific job functions
Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
Ability to use computers and other communication systems required to perform job functions
Perform repetitive hand and arm motions
Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
Pull or push up to 75 lbs. on occasion
Stand 100% of the time, frequently walking short distances
Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
Meet established volume activity standards for the position
Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
Have sufficient visual ability to check ID cards, checks, invoices and other written documents
08/24/2021: Change in job code from 131/132 to SF job code 1300594
Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.
If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************
$46k-67k yearly est. 7d ago
Automotive Document Specialist/Admin
Echopark Automotive
Quality assurance specialist job in Cary, NC
EchoPark Automotive is one of the fastest growing brands within the automotive industry. We are building a business based on doing things the right way. From the way we treat our guests, take pride in our work and share opportunities for our employees to grow as we grow. We are proud of what we're doing here and would love to tell you about our opportunities!
Job Description
EchoPark Automotive is hiring Customer Service Representatives for our location in Cary, NC! As a Customer Service Representative, which we call Document Specialists, you will play an important role in the smooth and friendly guest experience at our store. If you're a self-sufficient, resilient person who enjoys working in a fast-paced, fun environment, then we're looking for you. As a Document Specialist, you will be responsible for accurate and timely execution of the financial documentation process.
What You'll Do:
Assist with the final steps of the purchase process
Provide accurate and timely completed paperwork for successful processing
Check all paperwork for correct title, lien information, taxes, etc.
Verify insurance, trade payoffs and obtain deposits
What We're Looking For:
Demonstrated customer service and attention to detail
Experience in a retail environment
Be transparent
Take the high road
Willingness to learn
Take ownership
Celebrate small successes
What We Offer:
$36,000 - $50,000 based on experience with monthly bonus opportunities
Health, Dental and Vision Insurance
401k with 4% company match
Paid vacation
Access to leadership and personal development programs
Casual dress
Additional Information
All your information will be kept confidential according to EEO guidelines.
$37k-66k yearly est. 33d ago
Quality Assurance Senior Associate
Actalent
Quality assurance specialist job in Holly Springs, NC
Job Title: Quality Assurance Senior AssociateJob Description We are seeking a dedicated and detail-oriented Quality Assurance Senior Associate to join our team. This fully onsite role requires shift work that includes weekends and possibly nights. Once established, the shift schedule will remain stable. The role is pivotal in ensuring adherence to GMP quality requirements and involves working closely with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations.
Responsibilities
* Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations.
* Ensure facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and internal requirements relating to GMP, GDP, Safety, and other controls.
* Drive closure/completion, including reviewing and approving cGMP processes, procedures, documents, and records, including but not limited to deviations, investigations, and corrective actions/preventative actions (CAPAs).
* Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.
* Oversee and provide guidance during on-the-floor analytical testing.
* Ensure that changes potentially impacting product quality are assessed according to procedures.
* Investigate and document deviations from established procedures per guidelines.
* Alert Senior management of quality, compliance, supply, and safety risks.
* Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
* Identify and implement continuous improvement opportunities within processes and systems.
* Support and represent PQA during audits and inspections and may directly interact with regulatory agencies during on-site inspections.
Essential Skills
* Quality assurance expertise
* Manufacturing experience
* Experience with Batch Records and Deviations
* QA Oversight
* Experience in GNP Facilities
* PQA or Manufacturing experience, preferably in Drug Substance
Additional Skills & Qualifications
* High school diploma/GED with 4 years of work experience, or
* Associate degree with 2 years of work experience, or
* Bachelor's degree with 6 months of work experience, or
* Master's degree
Work Environment
This role involves providing on-the-floor guidance and manufacturing support, overseeing compliance in execution, reviewing Batch Records, and approving SOPs. You will engage in deviation reviews and assist in problem-solving with a quality mindset within a manufacturing setting.
Job Type & Location
This is a Contract position based out of Holly Springs, NC.
Pay and Benefits
The pay range for this position is $31.00 - $34.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Holly Springs,NC.
Application Deadline
This position is anticipated to close on Jan 28, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$31-34 hourly 5d ago
Quality Assurance Senior Associate
The Steely Group
Quality assurance specialist job in Holly Springs, NC
The Sr. Associate, Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations.
The Sr Associate, PQA position will facilitate real-time decision-making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance.
Responsibilities:
Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support.
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
Oversee and provide guidance during on-the-floor analytical testing.
Ensure that changes that could potentially impact product quality are assessed according to procedures.
Ensure that deviations from established procedures are investigated and documented per procedures.
Alert senior management of quality, compliance, supply and safety risks.
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
Identification and implementation of continuous improvement opportunities within our processes and systems.
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
Requirements / Qualifications:
High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required.
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment. Strong GMP and GDP Behaviors.
Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations.
Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.
Quality assurance specialist job in Holly Springs, NC
Pay $31-$33 per hr.
Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule.
Must have: Manufacturing and PQA background
Responsibilities:
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
$31-33 hourly 5d ago
Quality Assurance Operations Manager
Boston Analytical 4.2
Quality assurance specialist job in Morrisville, NC
The Quality Assurance Operations Manager supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports).
PRIMARY DUTIES AND RESPONSIBILITIES
Provide direct oversight to QA operations staff.
Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.
Review, approve Laboratory test data and reports.
Prepare and approve certificates of Analysis.
Support activities related to internal and external audits.
Represent site Quality group during Client and regulatory audits.
Collaborate with Laboratory management to support company goals.
Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness.
Actively participate in operational excellence programs/initiatives.
Review laboratory protocols and reports for accuracy and compliance to cGMP's, as applicable.
Site system owner for OOS, complaint, and deviation programs.
Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation.
Completes required actions for identified corrective/preventive actions for the Quality department.
REQUIREMENTS & QUALIFICATIONS
Qualification include a Bachelor's degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development.
DESIRED SKILLS
Enthusiastic, team player, collaborative across all departments to achieve the common goals.
Ability to focus on internal processes while maintaining focus on client needs.
Ability to work in a fast paced, dynamic environment.
Experience with LEAN implementation.
Familiarity with laboratory information management systems.
ISO 17025 or 9001 experience and knowledge.
Demonstrated ability to foster a Quality Culture across the organization.
Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.
$73k-105k yearly est. 21d ago
Quality Assurance Senior Associate
Us Tech Solutions 4.4
Quality assurance specialist job in Holly Springs, NC
The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance
**Key Responsibilities:**
+ Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
+ Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
+ Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.
+ Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
+ Oversee and provide guidance during on-the-floor analytical testing.
+ Ensure that changes that could potentially impact product quality are assessed according to procedures.
+ Ensure that deviations from established procedures are investigated and documented per procedures.
+ Alert senior management of quality, compliance, supply and safety risks.
+ Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
+ Identification and implementation of continuous improvement opportunities within our processes and systems.
+ Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site
**Basic Qualifications:**
+ High school/GED + 4 years work experience or
+ Associate + 2 years work experience or
+ Bachelor + 6 months work
**Must Have Skill Sets:**
+ Previous work on GNP Facilities
+ PQA or Mfg. preferably Drug Substance Experience
+ Previous work with Batch records/Deviations/Qa Oversight
+ Nice to have B.S. degree
**Day to Day Responsibilities:**
+ On the floor guidance/Mfg. support
+ Oversee compliance in execution
+ Batch Record Review
+ SOP review/Approvals
+ Deviation Review
+ Help Mfg. Problem solves with Quality mindset
**About US Tech Solutions:**
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** .
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
$47k-65k yearly est. 6d ago
Plan Document Specialist
Ascensus 4.3
Quality assurance specialist job in Greensboro, NC
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch personalized service from local TPAs backed by the strength and security of a large national firm, Ascensus. Our roots go back decades, with nearly 30 outstanding legacy firms now joined together to deliver unmatched levels of service, innovation and expertise to a fast-growing client base from coast to coast. The FuturePlan team includes more than 500 credentialed plan professionals, 60 actuaries, and one of the industry's largest in-house ERISA teams. Learn more at FuturePlan.com.
Section 1: Position Summary
Responsible for the following tasks related to basic to medium complexity retirement plans:
Draft plan document including new plan documents and plan restatements
Draft plan amendments
Prepare/update Summary of Plan Description and other related documents
Prepare IRS submissions
Prepare plan termination documents and submissions
Prepare annual notices
Perform technical research to answer compliance questions or resolve compliance issues
Work with Relationship Consultant to ensure signed documents are accurate and received timely
Complete assigned projects timely, accurately and in a cost effectively manner
Proactively participate in process improvement and innovation of current systems
Ensure client plan document files and records are organized and up to date
Commitment to ongoing pension education along with staying current with regulations and law changes
Enter consulting time in timekeeping system daily
Update workflow system daily
Perform Special projects
Other duties as assigned
Section 3: Experience, Skills, Knowledge Requirements
SKILLS NEEDED
Excellent verbal and written communication skills, including the ability to communicate technical ideas
Must possess strong organizational skills
Must have knowledge of a variety of computer software applications in word processing, spreadsheets and database software
Self-starter who will take responsibility for completing tasks in a timely fashion
Work requires continual attention to detail in reviewing materials, managing multiple projects, establishing priorities and meeting deadlines
Dependable with excellent follow through on commitments and responsibilities
Conceptual and analytical
Ability to work in a team environment and also work independently as appropriate
Ability to work in fast paced, ever changing office environment
Must be willing to maintain a flexible work schedule and work overtime as needed
EXPERIENCE NEEDED
A minimum of 2 years of retirement plan administration experience or equivalent preferred
TRAVEL REQUIREMENTS
None
PHYSICAL DEMANDS
Must be able to sit for long periods (at least 8 hours per day).
Must be able to work on a computer at least 8 hours per day (includes looking at a monitor, and typing using a keyboard and mouse).
EDUCATION/TRAINING NEEDED
B.A. or B.S. degree preferred
ASPPA designation or actuarial exams preferred
We are proud to be an equal opportunity employer.
Be aware of employment fraud. All email communications from Ascensus or its hiring managers originate ******************
******************
email addresses. We will never ask you for payment or require you to purchase any equipment. If you are suspicious or unsure about validity of a job posting, we strongly encourage you to apply directly through our website.
$44k-72k yearly est. Auto-Apply 6d ago
Quality Assurance Senior Associate
Actalent
Quality assurance specialist job in Holly Springs, NC
We are seeking a dedicated Quality Assurance Senior Associate to join our team. This fully onsite position follows a stable shift schedule that includes weekends and possibly nights. The role requires a background in manufacturing and PQA. As a Sr. Associate in Plant Quality Assurance, you will work directly with plant manufacturing and support groups on bulk drug substance manufacturing and new product introductions. You will facilitate real-time decision-making to ensure adherence to GMP quality requirements and foster a strong partnership between Manufacturing and Quality staff.
Responsibilities
* Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations.
* Ensure compliance of facilities, equipment, materials, organization, processes, and procedures with applicable regulations and requirements relating to GMP, GDP, Safety, and other controls.
* Drive closure and completion of cGMP processes, procedures, documents, and records, including review and approval of deviations, investigations, and corrective/preventative actions (CAPAs).
* Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.
* Oversee and provide guidance during on-the-floor analytical testing.
* Assess changes that could potentially impact product quality according to procedures.
* Investigate and document deviations from established procedures per guidelines.
* Alert management of quality compliance, supply, and safety risks.
* Provide project management support, leading efforts to achieve timely task completion and develop strategies for system implementation.
* Identify and implement continuous improvement opportunities within processes and systems.
* Support and represent PQA during audits and inspections, and directly interact with regulatory agencies during on-site inspections.
Essential Skills
* Quality assurance
* Manufacturing
* Batch Records
* Deviations
* QA Oversight
* Experience in GNP Facilities
* PQA or Manufacturing experience, preferably in Drug Substance
Additional Skills & Qualifications
* High school diploma/GED with 4 years of work experience or Associate degree with 2 years of work experience or Bachelor's degree with 6 months of work experience or Master's degree
Work Environment
This is an on-the-floor position providing guidance and support to manufacturing. You will oversee compliance in execution, review batch records, review and approve SOPs, and review deviations. You will also assist manufacturing in problem-solving with a quality mindset.
Job Type & Location
This is a Contract position based out of Holly Springs, NC.
Pay and Benefits
The pay range for this position is $31.00 - $34.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Holly Springs,NC.
Application Deadline
This position is anticipated to close on Jan 29, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
$31-34 hourly 5d ago
PT Quality Assurance Associate
Ahold Delhaize
Quality assurance specialist job in Chapel Hill, NC
A great career opportunity
Ahold Delhaize USA, a division of Netherlands-based Ahold Delhaize, is the parent company for Ahold Delhaize's U.S. companies, including its local brands, Food Lion, Giant Food, The GIANT Company, Hannaford and Stop & Shop, and the U.S. services companies, Retail Business Services, Peapod Digital Labs and ADUSA Supply Chain. When considered together, the local brands of Ahold Delhaize USA comprise the largest grocery retail group on the East Coast and the fourth largest grocery retail group in the nation, operating more than 2,000 stores and distribution centers across more than 20 states and serving millions of customers each week through a uniquely local omnichannel experience. The Ahold Delhaize USA company team includes just over 100 associates across all East Coast office locations.
A great career opportunity
Ahold Delhaize USA, a division of Netherlands-based Ahold Delhaize, is the parent company for Ahold Delhaize's U.S. companies, including its local brands, Food Lion, Giant Food, The GIANT Company, Hannaford and Stop & Shop, and the U.S. services companies, Retail Business Services, Peapod Digital Labs and ADUSA Supply Chain. When considered together, the local brands of Ahold Delhaize USA comprise the largest grocery retail group on the East Coast and the fourth largest grocery retail group in the nation, operating more than 2,000 stores and distribution centers across more than 20 states and serving millions of customers each week through a uniquely local omnichannel experience. The Ahold Delhaize USA company team includes just over 100 associates across all East Coast office locations.
At Ahold Delhaize USA, we embrace and celebrate diversity. Our employees and prospective employees are treated with fairness, respect and dignity. We provide an equal opportunity workplace committed to hiring, training, compensating, and promoting persons based on their talents and abilities and without regard to race, religion, color, national origin, gender, sexual orientation, age, family status, veteran status, disability status, or any other applicable characteristics protected by law.
$46k-67k yearly est. 7d ago
Learn more about quality assurance specialist jobs
How much does a quality assurance specialist earn in Burlington, NC?
The average quality assurance specialist in Burlington, NC earns between $38,000 and $104,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.
Average quality assurance specialist salary in Burlington, NC
$63,000
What are the biggest employers of Quality Assurance Specialists in Burlington, NC?
The biggest employers of Quality Assurance Specialists in Burlington, NC are: