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Qa specialist • manchester nh
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Bridge to thousands of biopharma companies and their patients.Our investment is in People who make an impact, drive progress and create a better tomorrow.
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Our purpose is sustaining energy and water for life, and it is demonstrated in everything we do as a business, and as an employee team.
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DEKA R&D has an immediate opening for a Quality Specialist to work in the Quality Department in a dynamic Medical Device Research and Development environment.
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Job Description • • : The Inventory Specialist at DHL is responsible for managing and maintaining accurate inventory records within the warehouse.
Your duties will include conducting regular inventory ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
QA Training Supervisor
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QA Training Supervisor
PCI Pharma ServicesBedford, NH, USAjob_description.job_card.variable_days_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionTrack and analyze training completion rates, effectiveness, and compliance metrics to ensure all employees remain current with required training. Generate and report training compliance metrics for management reviews, audits, and inspections. Ensure that training documentation and records are properly maintained in compliance with GMP and regulatory requirements. Support audits and regulatory inspections by providing training records and demonstrating training program effectiveness. Supervise, mentor, and develop QA Training personnel, providing coaching and career development opportunities. Establish clear performance expectations, conduct regular performance reviews, and provide ongoing feedback. Foster a collaborative and growth-oriented environment, ensuring the training team is well-equipped to support business needs. Lead continuous improvement initiatives to enhance training efficiency and effectiveness. Support site-wide training initiatives, including new system implementations, procedural updates, and quality initiatives. Partner with cross-functional teams to assess training needs and develop tailored solutions. Perform other duties as assigned. Ability to communicate effectively through speech, vision, hearing, and written word. Capable of managing multiple projects simultaneously in a complex environment. Must be able to sit or stand for prolonged periods and occasionally lift up to 20 pounds. Requires occasional travel (~10%). Enclosed Document Control Filing Rooms : Frequent work in secure and enclosed filing rooms to manage, organize, and archive controlled documents in compliance with GMP requirements. Office Setting : Standard office environment with desk work, computer use, and meetings. Production Facility Areas : Occasional presence in cleanroom or production facility areas to collaborate with staff and support QA-related activities. Bachelor’s degree in a relevant field with 5+ years of experience in a cGMP training environment, OR High school diploma or associate’s degree with 10+ years of experience in a regulated industry. 2-3 years of supervisory experience in a QA training or compliance role. 5+ years of experience in GMP training within a regulated industry (pharmaceutical, biotech, or medical device). Experience with electronic Learning Management Systems (LMS) and training compliance tracking. Strong knowledge of FDA (21 CFR Parts 210, 211 & 820) and EU regulatory requirements related to training and personnel qualification.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The QA Training Supervisor is responsible for managing the QA Training team and ensuring comprehensive training programs for the Manchester (MHT) sites, with occasional support for other locations. This role includes developing and delivering training programs, overseeing new hire orientation, tracking training metrics, and mentoring QA Training personnel to support compliance with GMP and regulatory requirements. The QA Training Supervisor plays a critical role in ensuring personnel are properly trained to perform their job functions in alignment with quality and compliance standards.
Essential Duties and Responsibilities : To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Training Program Oversight
- Manage and lead the QA Training team, ensuring effective training delivery for Manchester (MHT) sites and supporting other sites as needed.
- Develop, implement, and maintain comprehensive training programs to ensure compliance with GMP, FDA (21 CFR Parts 210, 211, & 820), and EU regulatory requirements.
- Oversee the New Hire Orientation program, ensuring new employees receive the necessary training for GMP compliance and company policies.
- Develop and maintain training curricula, materials, and SOPs related to QA training.
- Ensure that training programs are continuously updated to align with regulatory changes and best practices.
- Support and coordinate cross-training initiatives to enhance workforce flexibility and operational efficiency.
Training Metrics & Compliance
Team Development & Leadership
Additional Responsibilities
Special Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications : The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
Experience
LI-LL1
Join us and be part of building the bridge between life changing therapies and patients.