Quality Assurance Specialist

2 months ago

Gilroy, United States SOFIE Full time

Job Description | Quality Assurance Specialist (QAS) I

Title | Quality Assurance Specialist I

Department | Quality & Compliance

Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager)

Overview

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

Essential Duties and Responsibilities

▪              Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.

▪              Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.

▪              Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team.

▪              Write, review, approve, and implement procedures, specifications, processes, and methods as required.

▪              Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.

▪              Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.

▪              Ensure that personnel are properly trained and qualified. Ensure that the training is documented.

▪              Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.

▪              Liaise with internal and external inspectors and representatives, particularly on QA-related topics.

▪              Oversee the metrology program at the site (i.e., equipment, personnel qualifications, validations, etc.).

▪              Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.

▪              Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.

▪              Review trends (e.g., environmental monitoring, deviations, facility issues, etc.) to initiate corrective and preventive actions and/or for continuous process improvement.

▪              Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g., gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.

▪              Ensure any deviations from normal procedures are documented and justified.

▪              Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e., follow and maintain corporate CAPA, deviation, and OOS protocols).

▪              Ensure compliance to all applicable standard operating procedures and regulations, including 21 CFR Part 212 (and 211 as needed) requirements.

▪              Ensure product complaints are managed in a manner consistent with Company SOPs and FDA regulations.

▪              Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.

▪              Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.

▪              Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.

▪              Expected extensive knowledge of at least one SOFIE product.

▪              Other responsibilities as required.

Qualifications

▪              Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred.

▪              Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

▪              Quality, Pharmacy, or CGMP manufacturing experience preferred.

▪              Knowledge of USP, FDA, and cGMP regulations preferred.

▪              Knowledge of how and ability to write, review, and revise SOPs required.

▪              Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

▪              Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

▪              Ability to write reports, business correspondence, and procedure manuals required.

▪              Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.

▪              Ability to define problems, collect data, establish facts, and draw valid conclusions required.

▪              Ability to solve problems and handle issues required.

▪              Proficient in MS Office applications required.

▪              Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.

Requirements for Quality Assurance Specialist (QAS) I

▪              Associate’s or Bachelor’s Degree, at minimum

•             Relevant certifications and/or experience may be substituted in lieu of this requirement

▪              1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience

  • Quality Assurance Specialist

    4 weeks ago

    Gilroy, California, United States SOFIE Full time

    Job Title: Quality Assurance SpecialistJoin SOFIE as a Quality Assurance Specialist and play a critical role in ensuring the quality and compliance of our products.About the RoleThe Quality Assurance Specialist will be responsible for overseeing the Quality Assurance program and the Quality Management System at the site level. This includes maintaining...

  • Quality Assurance Specialist

    2 weeks ago

    Gilroy, California, United States SOFIE Full time

    Job Title: Quality Assurance SpecialistJob Description:As a Quality Assurance Specialist at SOFIE, you will be responsible for overseeing the Quality Assurance program and Quality Management System at a single manufacturing facility. Your primary goal will be to ensure product quality and regulatory compliance.Key Responsibilities:Maintain oversight of the...

  • Quality Assurance Manager

    2 weeks ago

    Gilroy, California, United States SOFIE Full time

    Job Title: Quality Assurance SpecialistDepartment: Quality & ComplianceReports To: Regional Manager, Quality Assurance (or equivalent QA Manager)Overview:The Quality Assurance Specialist plays a critical role in ensuring the quality of our products and services. This position is responsible for developing and implementing quality assurance processes,...

  • Quality Assurance Specialist

    1 week ago

    Gilroy, California, United States SlingShot Connections Full time

    Job DescriptionSlingShot Connections is seeking a Quality Assurance Specialist to ensure the highest quality standards in our electronics manufacturing environment. As a key member of our team, you will be responsible for implementing and maintaining quality check procedures, documenting inspection results, and collaborating with production to improve...

  • Quality Assurance Inspector

    2 weeks ago

    Gilroy, California, United States SlingShot Connections Full time

    Job DescriptionSlingShot Connections is seeking a highly skilled Quality Assurance Inspector to join our team. As a key member of our production team, you will be responsible for ensuring the highest quality standards are met in our manufacturing process.Key Responsibilities:Conduct quality checks and inspections to ensure compliance with company procedures...

  • Quality Assurance Inspector I or II

    3 weeks ago

    Gilroy, United States SlingShot Connections Full time

    Job DescriptionJob Description**** POITION IS LOCATED IN MORGAN HILL****ESSENTIAL DUTIES AND RESPONSIBILITIES• Ensure that all of the quality check procedures put in place by company are followed duringproduction phase• Document inspection results by completing reports and logs• Keeps measurement equipment operating by following operating...

  • Clinical Rehabilitation Specialist

    1 month ago

    Gilroy, California, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Job Title: Clinical Rehabilitation SpecialistMLee Healthcare Staffing and Recruiting, Inc is seeking a dedicated and skilled Clinical Rehabilitation Specialist to join our esteemed healthcare team.In this role, you will be instrumental in promoting clinical excellence within the Occupational, Physical, and Speech Therapy teams, as well as among support staff...

  • Warehouse Operations Specialist

    2 weeks ago

    Gilroy, California, United States Infinity Staffing Full time

    Job DescriptionInfinity Staffing is seeking a skilled Warehouse Operations Specialist to join our team. As a Forklift Operator, you will be responsible for safely and efficiently loading and unloading pallets from trucks, as well as performing other warehouse duties.Key Responsibilities:Loading and unloading pallets from trucksOperating a forklift to move...

  • Clinical Rehabilitation Specialist

    1 month ago

    Gilroy, California, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Job Title: Clinical Rehabilitation SpecialistWe are seeking a highly skilled and dedicated Clinical Rehabilitation Specialist to join our esteemed healthcare team at MLee Healthcare Staffing and Recruiting, Inc. As a key member of our rehabilitation services team, you will play a vital role in promoting clinical excellence and providing exceptional patient...

  • Sanitation Quality Assurance Supervisor

    2 months ago

    Gilroy, California, United States Jobot Full time

    Sanitation Supervisor - Food ProductionJobot, a leader in sustainable food ingredients, is seeking a dedicated and knowledgeable Sanitation Supervisor to enhance our team within the food production industry. The successful candidate will possess a robust background in developing and overseeing sanitation initiatives while ensuring adherence to cleanliness...

  • Clinical Rehabilitation Specialist

    2 weeks ago

    Gilroy, California, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Job Title: Clinical Rehabilitation SpecialistMLee Healthcare Staffing and Recruiting, Inc is seeking a dedicated and skilled Clinical Rehabilitation Specialist to join our esteemed healthcare team.This role is instrumental in promoting clinical excellence within the Occupational, Physical, and Speech Therapy teams, as well as among support staff like Rehab...

  • Acute Care Setting

    1 month ago

    Gilroy, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Clinical Rehabilitation Specialist Potential Sign-On Bonus Available / Competitive Pay / Full-Time Day Position / Comprehensive Benefits Package Position Overview: MLR is thrilled to announce an opportunity for a dedicated and skilled Clinical Rehabilitation Specialist to join our client's esteemed healthcare team. In this role, reporting to the Rehab...

  • Physical Therapist PRN Specialist

    2 weeks ago

    Gilroy, California, United States Concentra Full time

    Job Title: Physical Therapist PRNConcentra is seeking a skilled Physical Therapist PRN to join our team. As a Physical Therapist PRN, you will play a vital role in providing exceptional care to our patients.Job Summary:We are looking for a highly motivated and experienced Physical Therapist PRN to join our team. The successful candidate will be responsible...

  • Pediatric Healthcare Specialist

    1 week ago

    Gilroy, California, United States Bay Area Community Health Full time

    Bay Area Community Health is committed to delivering high-quality patient-centered care. As a Pediatrics Physician, you will work as part of a multi-disciplinary team to achieve the organizational goals of the clinic through the delivery of primary medical and educational care. Your responsibilities will include examination, evaluation, diagnosis, treatment,...

  • Community Engagement Specialist

    1 week ago

    Gilroy, California, United States SynergG Coworking, LLC Full time

    Job Title: Community Engagement SpecialistJob Summary:The Community Engagement Specialist will be responsible for cultivating a professional, productive, and welcoming environment at SynerG Coworking, LLC. This role will provide support to members, engage with the community, and help drive membership growth and retention.Key Responsibilities:Develop and...

  • Hearing Aid Specialist

    2 weeks ago

    Gilroy, California, United States Miracle-Ear Full time

    Job OpportunityWe are seeking a skilled Hearing Aid Specialist to join our team at Miracle-Ear. As a key member of our Corporate Retail Team, you will play a vital role in helping individuals with hearing loss.Key Responsibilities:Provide expert hearing aid counseling and consultation to customers.Conduct audiological tests and review results with...

  • Nephrology Nurse Specialist

    2 weeks ago

    Gilroy, California, United States Satellite Healthcare Full time

    Job SummaryWe are seeking a highly skilled and compassionate Nephrology Nurse Specialist to join our team at Satellite Healthcare, Inc. As a Staff Nurse, you will play a vital role in delivering exceptional patient care and making a meaningful difference in the lives of those living with kidney disease.Key ResponsibilitiesParticipate in professional role...

  • Nephrology Nurse Specialist

    2 weeks ago

    Gilroy, California, United States Satellite Healthcare Full time

    As a Nephrology Nurse Specialist at Satellite Healthcare, you will play a vital role in delivering exceptional care to patients with kidney disease. Your expertise will be essential in developing and implementing individualized treatment plans, ensuring that our patients receive the highest level of care.**Key Responsibilities:**Develop and implement...

  • Retail Merchandising Specialist

    2 weeks ago

    Gilroy, California, United States Kendal Floral Full time

    As a Retail Merchandising Specialist at Kendal Floral, you will be responsible for representing our company by merchandising and selling fresh-cut flower bouquets and arrangements at Costco. This role requires managing inventory, maintaining merchandise based on set criteria, and providing excellent customer service to Costco members.Key...

  • Pediatric and Adult Home Health Nursing Specialist

    6 days ago

    Gilroy, California, United States Maxim Healthcare Service Full time

    Seeking an exceptional Pediatric and Adult Home Health Nursing Specialist to join our team at Maxim Healthcare Services in San Jose, California. As a dedicated healthcare provider, you will work closely with patients and families to deliver high-quality care in the comfort of their own homes.About the RoleThis is an exciting opportunity to work with...