Quality Assurance Associate I
3 months ago
SUMMARY/OBJECTIVE
This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Tedor Pharma compliance initiatives, including
following all quality and division/company policy requirements. Helps to ensure that all Tedor Pharma products meet quality requirements by supporting all assigned quality aspects of product approval. The
QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved.
RESPONSIBILITIES
1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management;
2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
3. Supports resolution of technical and compliance issues/gap analysis.
4. Aides implementation of Quality Systems/System Improvements.
5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas.
7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.
8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA.
9. Work in coordination with regulatory affairs group in support of ANDA submissions.
10. Provides QA review/approval of all cGMP documents associated with manufacture of product.
11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
12. Authors or revises SOPs as necessary.
13. Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling,
good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
15. Assist in development of special department projects and work in conjunction with quality management.
16. Other duties as assigned.
COMPETENCIES
1. Project Management
2. Technical Capacity.
3. Discretion.
4. Problem Solving/Analysis.
5. Decision Making.
6. Communication Proficiency.
7. Collaboration Skills.
8. Learning Agility
9. Managing Changing Priorities
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position requiring 40 or more hours of work per week.
-
Quality Assurance Specialist
4 weeks ago
Cumberland, Rhode Island, United States inMusic Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products.About the Role:The Quality Assurance Specialist will be responsible for testing our products before public release to...
-
Quality Assurance Specialist
2 days ago
Cumberland, Maryland, United States Berry Global Full timeAbout the RoleWe are seeking a highly motivated Quality Assurance Specialist to join our team at Berry Global. As a Quality Assurance Specialist, you will play a crucial role in ensuring that our products meet the highest quality standards. Your primary responsibility will be to conduct quality control inspections on components manufactured on all production...
-
Quality Assurance Specialist
3 weeks ago
Cumberland, Maryland, United States Berry Global Full timeAbout Berry GlobalBerry Global is a leading provider of innovative packaging solutions. Our company values diversity and has a strong commitment to sustainability.As a Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and safety. This position requires a minimum of 2 years of...
-
Quality Assurance Specialist
3 weeks ago
Cumberland, Maryland, United States Berry Global Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Technician to join our team at Berry Global.This role is responsible for ensuring that all products meet our high standards of quality, safety, and regulatory compliance. As a key member of our production team, you will work closely with cross-functional teams to identify and resolve quality...
-
Quality Assurance Specialist
3 weeks ago
Cumberland, Rhode Island, United States NEUROTECH U S A Full time**Job Overview**We are seeking an experienced Validation and Quality Lead to join our team at Neurotech USA. This role will provide full-time oversight to the validation program, including providing validation program expertise, documentation review, and validation strategy.The successful candidate will have a solid background in Quality Assurance/Systems,...
-
Quality Assurance Floor Supervisor
3 weeks ago
Cumberland, Rhode Island, United States NEUROTECH U S A Full timeAbout the RoleNEUROTECH U S A is seeking a Quality Assurance Floor Supervisor to oversee QA activities on the production floor, ensuring compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. This role involves supervising QA staff, monitoring production processes, and collaborating with...
-
Quality Assurance Tester
2 months ago
Cumberland, United States inMusic Full timeDiscover More About Us: inMusic is a family of leading music technology and consumer electronic brands. We live and breathe music. We incorporate and build upon the latest engineering, design, and technology in the DJ, Music Production, Pro Audio, Musical Instrument, and Consumer Electronics industries. Some of our leading brands are: Akai Professional,...
-
Quality Assurance Technician
4 days ago
Cumberland Center, Maine, United States LGC Group Full timeOverview of the RoleThe Data Review Specialist plays a crucial role in ensuring the accuracy and quality of customer data. This involves daily management of customer data, including processing, review, and approval of data reports.Main Responsibilities:Daily management of customer data, including processing, review, and approval of data reports.Accurate data...
-
Quality Assurance Manager
2 weeks ago
Cumberland, United States Tedor Pharma Services Full timeThe ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. ResponsibilitiesDevelop standardized production, quality, and customer-service standards Identify potential...
-
Quality Assurance Lead
6 days ago
New Cumberland, Pennsylvania, United States Chenega Corporation Full timeAbout the OpportunityWe are seeking a seasoned Quality Control Manager to join our team at the Defense Distribution Center, Susquehanna. As a key member of our leadership team, you will be responsible for overseeing the entire Quality Control program, ensuring that all work meets contract requirements and industry standards.ResponsibilitiesDevelop and...
-
Regulatory Affairs and Quality Associate
5 days ago
Cumberland, Rhode Island, United States Tedor Pharma Services Full timeResponsibilitiesThe Regulatory Affairs and Quality Associate is responsible for providing support to GMP investigations, validation documentation review and approval, identifying gaps within existing Quality Systems, and proposing solutions for functional management.The successful candidate will also participate in activities associated with primary batch...
-
Food Service Quality Assurance
3 weeks ago
Cumberland, Maryland, United States DiningRD Full timeAbout DiningRDDiningRD is a company that values and respects its team members. We are committed to improving the lives of seniors through our consulting services.The ideal candidate will have a passion for working with seniors and improving their nutrition and well-being.We offer a competitive salary of $70,000 - $90,000 per year, flexible schedule,...
-
Inspector of Quality Control
3 weeks ago
Cumberland, Maryland, United States Berry Global Full timeKey ResponsibilitiesCarry out regular inspections on components manufactured on all production machines to ensure they meet customer specifications.Collaborate with production and customer service teams to resolve quality-related issues, including Corrective Action/Preventative Action (CAPA) and quality alerts.Determine the disposition of suspect products...
-
Packaging Quality Control Manager
3 weeks ago
Cumberland, Maryland, United States Berry Global Full timeAs a Packaging Quality Control Manager at Berry Global, you will oversee the quality control processes for our packaging solutions. Your primary responsibility will be to develop and implement effective quality control procedures to ensure compliance with industry standards and regulations. With a minimum of 2 years of experience in Quality Assurance, you...
-
Service Desk Associate
4 weeks ago
Cumberland, United States Weis Markets, Inc. Full timeOverview Looking for a company that treats associates with respect, understanding, and appreciation? Looking for a company that is passionate about teamwork and the growth of it's associates and communities? That's WEIS! Location Address: 15300 Mcmullen Highway SW Ste 101 Job Description: ESSENTIAL DUTIES AND RESPONSIBILITIES The Service Desk Associate...
-
Service Desk Associate
4 weeks ago
Cumberland, United States Weis Full timeOverviewLooking for a company that treats associates with respect, understanding, and appreciation? Looking for a company that is passionate about teamwork and the growth of it's associates and communities? That's WEIS!Location Address:15300 Mcmullen Highway SW Ste 101Job Description:ESSENTIAL DUTIES AND RESPONSIBILITIESThe Service Desk Associate is...
-
Service Desk Associate
4 weeks ago
Cumberland, United States Weis Full timeOverviewLooking for a company that treats associates with respect, understanding, and appreciation? Looking for a company that is passionate about teamwork and the growth of it's associates and communities? That's WEIS!Location Address:15300 Mcmullen Highway SW Ste 101Job Description:ESSENTIAL DUTIES AND RESPONSIBILITIESThe Service Desk Associate is...
-
Quality Assurance Scientist
4 days ago
Cumberland Foreside, United States LGC Group Full timeRequirementsTo be successful in this role, you will need:A degree in Medical Laboratory Science or a related science field (e.g., biology, chemistry, biochemistry)1-3 years of experience in a clinical chemistry lab or equivalent settingStrong organization and multitasking skillsExperience with various software programsPrevious working experience with...
-
Analyst I
2 weeks ago
Cumberland, United States Ask Staffing Full time"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: Compliance Analyst Location: Cumberland RI USA 02864 or 9501 East Shea Blvd Scottsdale, AZ 85260Duration: 6 months Pay rate: $ 35/hr. on W2. Job Description:Work Schedule: Mon-Fri 8:30am...
-
Manufacturing Operations Supervisor
4 weeks ago
Cumberland, Rhode Island, United States NEUROTECH U S A Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance Supervisor to join our team at Neurotech USA.Job SummaryThe Quality Assurance Supervisor will oversee QA activities on the production floor, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.This role involves supervising QA staff, monitoring...