Quality Auditor
SubCom
Position Overview The Quality Auditor is responsible for planning, executing, and reporting on internal and supplier audits, as well as facilitating corrective actions and continuous improvements to maintain compliance and enhance the overall quality of SubCom’s products/services. Responsibilities Audit Planning: Develop audit plans, schedules, and checklists to evaluate the effectiveness of the QMS in compliance with ISO 9001 requirements. Conduct Audits: Perform internal audits, supplier audits, and participate in third‑party audits to assess adherence to SubCom business and ISO 9001 standards. Evaluate processes, procedures, and documentation. Documentation Review: Examine quality documentation, including policies, procedures, work instructions, and records, to ensure accuracy and compliance with ISO 9001. Non‑Conformance Identification: Identify and document non‑conformances and areas of improvement. Clearly communicate findings to relevant stakeholders. Recommendations: Provide recommendations for corrective and preventive actions to address non‑conformances and improve the QMS. Follow‑Up: Monitor and track the progress of corrective actions and verify their effectiveness through follow‑up audits. Reporting: Prepare comprehensive audit reports with findings, conclusions, and recommendations. Present findings to management and relevant teams. Training: Conduct training sessions on ISO 9001 standards and quality best practices for employees as needed. Continuous Improvement: Actively participate in the continuous improvement of the QMS, suggesting enhancements and efficiencies. Regulatory Compliance: Stay current with ISO 9001 standards and relevant industry regulations. Ensure that the organization remains compliant and leads efforts to continually improve SubCom Quality Systems. Qualifications Bachelor’s Degree in Engineering, Business, or related field is preferred. Certified Lead Auditor to ISO-9001:2015 is preferred. Minimum of 3 years of progressive experience developing, implementing, and auditing ISO 9001:2015 Quality Systems. Experience performing and documenting supplier and internal process audits is essential. Background in developing, implementing, and auditing ISO-9001:2015 Quality Systems. Excellent communication and coaching skills at all levels from the shop floor to top management, including the ability to speak, read and write fluently in English. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Candidates for positions with SubCom must be legally authorized to work in the United States. Employment eligibility verification will be required at the time of hire. Visa sponsorship is not available for this position.
BENEFITS
SubCom offers a comprehensive benefits package, including but not limited to: competitive salaries, medical, dental, vision, life and disability insurance coverages, FSA, HSA, generous vacation, paid sick leave, paid parental leave, paid holidays, tuition reimbursement, adoption assistance, and a 401(k) plan with generous company match. Additionally, some positions may be eligible for shift differential.AFFIRMATIVE ACTION/EQUAL EMPLOYER OPPORTUNITY
SubCom is committed to providing a work environment that prohibits discrimination based on age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation. #J-18808-Ljbffr SubCom- Job Title: Quality Control SpecialistLocation: Portsmouth, NH (On-site)At Lonza, a leading contract development and manufacturing organization (CDMO), our people are our greatest strength. As a global leader in life sciences, we work together to develop innovative solutions...SuggestedFull timeContract work
- ...with a high degree of autonomy while partnering closely with GMP operators and manufacturing teams to provide real-time, on-the-floor Quality Assurance support for operational areas involved in GMP activities. This role is responsible for supporting compliance within...SuggestedFull timeTemporary workWork at officeNight shift
- QA Specialist V - Quality Risk Management (QRM)Location: Portsmouth, New Hampshire, USAAt Lonza, we are looking for a QA Specialist V - Quality Risk Management (QRM) to help strengthen our site-wide quality culture and support risk-based decision-making. In this highly...SuggestedFull time
- ...and relevant knowledge.What will you do:We are seeking a detail-oriented QA Specialist IV-Operations to support document review and quality oversight activities within a cGMP manufacturing environment. This role is responsible for reviewing and approving GMP...SuggestedFull timeTemporary workWork at officeMonday to Friday
- ...qualifications, skills, experience, and relevant knowledge.What will you do:We are seeking a QA Specialist II - Operations to provide real-time Quality Assurance support for GMP manufacturing operations. In this role, you will partner closely with Manufacturing and other operational...SuggestedFull timeTemporary workWork at officeDay shift
- ...communication skills, and the ability to influence a culture of quality and compliance across the organization.Audit & Inspection... ...strong organizational and problem-solving skillsCertified Quality Auditor (CQA) or similar certification preferredExperience in biologics...Full timeTemporary workWork at officeMonday to Friday
- ...Job Title : Quality Control Specialist Location: Portsmouth, NH (On-site) At Lonza, a leading contract development and manufacturing organization (CDMO), our people are our greatest strength. As a global leader in life sciences, we work together to develop innovative...Contract work
- ...you will play an important role in supporting the release of in-process and final product drug lots through analytical testing and quality control activities. Working within a GMP-regulated laboratory, you will perform chromatography-based assays, troubleshoot laboratory...Full time
- JobTitle: Quality Control Analyst I - Microbial ControlLocation: Portsmouth, NH, (On-site)As a QC Analyst I in Microbial Control at our Portsmouth site, you will support microbiological testing and monitoring activities to help ensure the safety and quality of drug products...Full timeShift workNight shiftWeekend work
- JobTitle: Quality Control Analyst II - Microbial Control (Night)Location: Portsmouth, NH, (On-site)As a QC Analyst II in Microbial Control at our Portsmouth site, you will support the testing of in-process and final product samples to ensure the safety and quality of drug...Full timeNight shift
- ...Leadership: Act as a lead for the EM department, influencing site-wide quality culture and operational strategy.Audit Frontline: Represent the... ...complex scientific data clearly to senior management and auditors.About LonzaAt Lonza, our people are our greatest strength. With...Permanent employmentFull timeMonday to FridayDay shift
- ...qualifications, skills, experience, and relevant knowledge.What you will do:The Sr. QA Compliance Specialist serves as a key member of the Quality Assurance organization and acts as a subject matter expert for Quality Systems and GMP Compliance. This role is responsible for...Full timeTemporary workWork at officeMonday to Friday
- ...candidate’s qualifications, skills, experience, and relevant knowledge.What will you do:The QA Compliance Specialist supports the site's Quality Systems and Compliance programs by helping ensure adherence to GMP regulations, internal quality standards, and regulatory...Full timeTemporary workWork at officeMonday to Friday
- ...Manufacturing Location: Portsmouth, NH, USA.Schedule: Monday - Friday, 0800-1700We are seeking an advanced laboratory professional to join our Quality organization in Portsmouth, NH, as an Analyst III, QC Analytical. Operating under general supervision, this senior bench-based role...Full timeMonday to Friday
- ...). Looking for the worker to Build Equipment Requalifications in Kneat. Responsibilities: Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of equipment. Drive/own the validation...Temporary work
$69 - $79.58 per hour
...Description Onsite: Portsmouth, New Hampshire Job Summary The QA Specialist – QA Compliance supports and maintains the site Quality Management System (QMS) by ensuring local procedures align with the company’s Group Quality Standards and applicable GMP...Hourly payWork at officeLocal area- Description The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies...
- ...ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy. Job Title: Quality Control Documentation Specialist Location: Portsmouth, NH, 03801 Duration: 8 Months Job Type: Temporary...Temporary workWork at office
- ...ambient). Looking for a worker to Build Equipment Requalifications in Kneat.Job Description:Provide Subject Matter Expert support to Quality Control, Manufacturing, and other departments for the design, operation, and troubleshooting of equipment.Drive/own the validation...Temporary work
$62 - $64.75 per hour
...-month contract role, you will play a key part in technical transfer activities, method/software validations, and ensuring overall quality control compliance in a fast-paced environment. location: Portsmouth, New Hampshire job type: Contract salary: $62.00 - 64...Hourly payContract workTemporary workWork experience placement- ...Wednesday – Saturday (7:00 AM – 5:30 PM) . We are seeking an organized and detail-oriented technical professional to join our Quality organization in Portsmouth, NH, as a QC Technical Services Analyst II . This critical role directly supports the rollout of our brand...Monday to FridayShift work
- ...8 Months Job Type: Temporary Assignment Work Type: Onsite Summary This is an entry-level to junior-level Quality Control Associate / QC Laboratory Analyst position supporting laboratory testing and routine QC activities in a GMP-regulated manufacturing...Temporary workWork at office
- ..., and relevant knowledge. What will you do: We are seeking an experienced QA Operations Specialist IV to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational...Temporary workWork at officeNight shift
- ...and relevant knowledge. What will you do: We are seeking an experienced QA Operations Specialist III to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational...Temporary workWork at officeNight shift
$62 per hour
...industry. Proficiency with laboratory computer systems and data interpretation. Preferred: ~ Prior experience with GMP Quality Systems such as TrackWise or LIMS. #LI-MH1 skills: Laboratory Information Management Systems (LIMS), Quality Control (QC)...Hourly payContract workTemporary workWork experience placement$66 per hour
...qualifications: Required: Bachelor's degree in Biochemistry or a related scientific discipline. 5+ years of hands-on Quality Control laboratory experience in a cGMP biologics manufacturing setting. Extensive experience with analytical techniques such as...Hourly payContract workTemporary workWork experience placementDay shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Auditor. Be the first to apply!



