Customer Quality Specialist II

2 weeks ago

Rochester, United States Visron Technical Full time

Details:

Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs.

The Customer Quality Specialist conducts and supports problem investigations (deviations), change controls and customer complaints in accordance with company procedures and current regulatory requirements, for sterile and non-sterile products. For complaints this includes managing the receipt, processing and monitoring of each complaint and providing the completed investigation to the customer within the required timeframe.

The Customer Quality Specialist completes review of laboratory data and completes final release of finished products. This position will serve as a frequent inter-organizational contact and will represent the QA department on teams for the Customers. This role is responsible for review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary.

This position interacts with manager and director levels of management in all departments in developing solutions and providing timely and accurate communication. As a Customer Quality Specialist, frequent interactions will occur with our customers including documentation approvals, deviations, change controls and various meetings and business reviews. The Customer Quality Specialist will serve as the main QA contact for customers regarding deviations, Change Controls, complaints, and any other quality concerns.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Quality System Guidance & Advice (30%)

Provides Quality Assurance consultation which may include:

  • Complaints, Deviations, change controls, laboratory and operations related items and standard operating procedure changes
  • Consultation must meet current regulatory requirements and be appropriate for the business.
  • Provide critical support during regulatory agency and customer audits
Receivers of guidance report:
  • Guidance is practical and provided in time to be actionable.
  • Interpretation of regulatory requirements is communicated in a way that is easily understood by the receiver.
  • Consultation meets current regulatory requirements and is appropriate for the business.
Safe, Effective Products (50%)
  • Assist/lead and close investigations the required time.
  • Ensure investigations are conducted according to the severity defined in the SOP and support the investigation team throughout the investigation. Propose CAPA if needed and ensure any identified CAPAs are implemented.
  • Participate to the recurrences analysis to define and deploy the appropriate CAPA
  • Review and release the commercial batches according to the schedule, including MFT batches needed to support sterile products.
  • Lead and complete complaint investigations.
  • Serve as the main contact for customers including attending routine meetings.
  • Review and challenge the quality agreement before approval by the quality managers.
  • To BOM updates, equipment recipe updates, batch cards changes, and other documents linked to your scope, required for the above changes.
  • Products meet customer needs and regulatory requirements and do not result in recalls.
  • No recalls or audit observations associated with released product
Effective, Efficient Quality System (20%)
  • Ensures standard operating procedures and processes meet current industry requirements and are efficient for the business.
  • Ensures CAPAs address root cause and reduce recurrence rates.
  • Reviews and approves documentation such as procedures, protocols, reports as required by regulations.
  • Ensures Change Controls are thorough and meet industry requirements.
  • Provides support during customer and regulatory inspections.
  • Ensures Quality Metrics are delivered.
KNOWLEDGE SKILLS & ABILITIES:
  • Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
  • Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
  • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
  • Written Communication: Can write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
  • Technical Learning: Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.
REQUIREMENTS:
  • Bachelor's Degree in Chemistry, Biology, Pharmacy, or related field.
  • Minimum of 2-5 years' experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.
  • QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality system.
  • Experience in audits and regulatory inspections (FDA & others).


Job Requirements

  • Research Specialist II

    7 days ago

    Rochester, United States The University of Rochester Full time

    The Research Specialist II provides direct research and teaching support at the professional level by taking charge of a segment of a larger project involving research of moderate complexity; or by working as an independent researcher in specialized, Research, Specialist, Neuroscience, Equipment, Laboratory, Research Coordinator, Technology, Education

  • Quality Specialist

    1 week ago

    Rochester, New York, United States Proclinical Full time

    Quality Specialist - Permanent - Rochester, NYProclinical is seeking a proactive and dedicated individual for a Customer Quality Specialist for a leading pharmaceutical company. This is a permanent position located in Rochester, NYPrimary Responsibilities:This role is ideal for those currently pursuing or who have completed a degree in Business...

  • Laboratory Referral Specialist I or II- Bridgeport, Connecticut

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Quality Assurance Specialist

    1 month ago

    Rochester Hills, United States Energy Steel Full time

    Quality Assurance Specialist (QA) – is responsible for the review and approval of objective evidence of quality of examination, inspection, and test results for conformance/compliance to Code, Energy Steel requirements, and customer purchase order requirements. The QA Specialist compiles the Energy Steel certification documents and releases material for...

  • Quality Assurance Specialist

    1 month ago

    Rochester Hills, United States Energy Steel Full time

    Quality Assurance Specialist (QA) – is responsible for the review and approval of objective evidence of quality of examination, inspection, and test results for conformance/compliance to Code, Energy Steel requirements, and customer purchase order requirements. The QA Specialist compiles the Energy Steel certification documents and releases material for...

  • Building Automation System Specialist II

    1 month ago

    Rochester, United States Harris Full time

    Your purpose of your role as a Building Automation System Specialist II As a BA System Specialist, you will primarily perform and develops sequence testing, project graphics, and point to point verification ensuring the system runs as efficiently as possible. Work as a part of a team at client or project job sites to ensure proper installation of...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Laboratory Referral Specialist I or II

    7 days ago

    Rochester, United States Mayo Clinic Health System Full time

    Why Mayo Clinic Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans - to take care of you and your family, now and in the...

  • Customer Solutions Specialist

    5 days ago

    Rochester, United States Rochester Promotions Firm Full time

    Job DescriptionJob DescriptionDo you enjoy working with people? Are you looking for an opportunity to challenge yourself and learn new skills? If you answered yes to these questions then you may just be the person our firm is looking for! We are actively searching for a dedicated customer solutions specialist to add to our diverse team of professionals.Our...

  • Credit Specialist II

    15 hours ago

    Rochester, United States US Tech Solutions Full time

    Role: Credit Specialist (Tier II)Duration: Jun 10, 2024 - Sep 6, 2024Location: 220 Kenneth Drive Rochester New York 14623Work Hours/Shift - 40; M-Th 12-9p, Friday 9-6pm; Monday- Wed are office days, Thursday and Friday are remotePay Rate: $24/Hour JOB DESCRIPTIONMitigates credit risk exposure by completing reviews of incoming clients utilizing client payroll...

  • Retail Customer Service Specialist

    2 days ago

    Rochester, United States The Sherwin-Williams Company Full time

    This is position is essential to the success of our retail stores. Customer Service Specialists work closely with wholesale and retail customers to determine their needs, answer their questions about Sherwin-Williams products, and recommend the right solutions. Customer Service Specialists are also expected to promptly resolve any customer concerns and...

  • Customer Service Specialist

    2 days ago

    Rochester, United States Harris Seeds Full time

    Job DescriptionJob DescriptionAt Harris Seeds, we pride ourselves on our friendly, knowledgeable, and dedicated team members who are passionate about the commitment to serving the agricultural industry and supporting our customers growing success. We are currently seeking a full-time Customer Service Specialist to provide exceptional customer service for our...

  • Customer Experience Specialist

    6 hours ago

    Rochester, United States British Swim School Full time

    Customer Experience Specialist Part Time Rochester A position at British Swim School is more than just a job, it is an opportunity to learn, grow, and make an impact in the lives of your community to ensure survival of the littlest. Compensation and Benefits: + Competitive pay based on experience and with possible opportunities for bonuses! + Paid training!...

  • Customer Service Specialist

    1 week ago

    Rochester, United States Fonte Surgical Supply, Inc. Part time $17 - $20

    Position Overview:As a Customer Service Specialist, you will be working directly in a retail setting or indirect via telephone with customers and their caregivers using your expertise in guiding them to make an informed decision.Qualifications:Must be motivated, willing to learn, and interact with our customers with a positive attitude. We will train the...

  • Retail Customer Service Specialist

    2 days ago

    Rochester, United States Sherwin-Williams Full time

    This is position is essential to the success of our retail stores. Customer Service Specialists work closely with wholesale and retail customers to determine their needs, answer their questions about Sherwin-Williams products, and recommend the right solutions. Customer Service Specialists are also expected to promptly resolve any customer concerns and...

  • Operations Support Specialist

    2 days ago

    Rochester, United States University of Rochester Full time

    POSITION SUMMARY: Responsible for the Customer Service Center, the main communication hub for University Facilities and Services, serving as the central point of contact in regards to service calls, alarms, emergency response, critical and non-critical operations information within a 24 hour facility operation. They work directly with all departments within...