Senior QA Compliance Coordinator Job Listing at Kelly Services in Cincinnati, OH (Job ID 10091459)

Description

Kelly Science & Clinical is seeking a Senior QA Compliance Coordinator near Cincinnati, OH.

Direct Hire
Shift: Monday - Friday 1st shift
Compensation: DOE 

SUMMARY

Reporting directly to the Senior Manager, Total Quality, the Quality Assurance Senior Compliance Coordinator will provide support to the Corporate Quality team by ensuring the company's policies and practices meet regulatory requirements in a food, cosmetic, and pharmaceutical environment.  The QA Senior Compliance Coordinator will be working directly with customers to complete or approve the customers' regulatory product documentation including customer quality questionnaires about the company, product quality statements, process procedures, product stability study reports, etc.  This person will control, organize and maintain proprietary documentation for the company and customers.  They will manage and maintain new QMS software system relative to position.  The position utilizes extreme attention to detail to ensure that the documents reflect our quality program.  The QA Senior Compliance Coordinator will also support the organization in other corporate quality programs including: quality internal and external auditing, document technical writing, product qualification practices, document control, quality and employee training.  This position will work with all levels of management and associates to facilitate problem-solving and ensure customer and regulatory quality standards are achieved. 

RESPONSIBILITES

• Completion and approval of customer quality documentation for site and product qualification (ie. Customer surveys, questionnaires).
• Creation and/or editing of product documents, procedures, supplier or service quality agreements, and other support materials. Produce electronic documentation in addition to hard copy manuals.
• Develop and maintain an electronic reservoir of up-to-date supplier product information. Maintain an organized filing system of original hard copy documents.
• Provide Corporate QA support to other CNA sites with customer complaints, investigations and reporting as requested.
• Navigate daily through customer specific software programs to update company's specifications and product information.

• Ensure any quality software / electronic software systems are compliant with current regulations.
• Support Document Control program at all Company sites by reviewing, revising, and publishing procedures or forms.  Route and obtain the specific approvals needed through electronic signature or manual wet signatures. 
• Perform administrative functions to support the team including, preparing reports, document filing, proofreading, audit / meeting notetaking, and correspondence. 
• Provide training and education of the quality management system and practices to personnel as required for operational readiness activities.
• Work independently on assigned projects and daily QA maintenance functions.
• Serve as quality lead on the development and maintenance of Quality Management Systems (QMS) based on company's global standards and regulations by collecting and analyzing data.
• Support on-site audits from customers and regulatory by taking notes in audits, preparing the audit response to customer, and providing supporting documentation.
• Complete assigned external audits with formal audit reports within a timely manner.
• Participates in Kaizen events, huddles, quality/safety walks, internal auditing, investigations, and 5S best practice events.  Ensures that actions items are completed in a timely manner.
• Perform other administrative and quality assurance duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES
 

• Attention to Detail
• Organizational skills
• Good communication skills – verbal and written.
• Excellent time management.
• Self-motivation, initiative
• Critical thinking.
• Working well independently as well as in a team.
• Being flexible.
• Determination and persistence.
• Being a quick learner.
• Project management skills

MINIMUM REQUIREMENTS
 

• Bachelor's degree or related discipline or equivalent combination of experience and education preferred.
• At least 4 years of progressive experience in a GMP manufacturing and / or laboratory environment.
• Worked in a GMP and ISO environment. Must have prior experience in a Quality Assurance role with knowledge of GDP requirements.
• GMP, GFSI, or ISO Certified Quality Auditor (ie ASQ). Able to perform supplier and service audits and write audit reports on behalf of company when needed.   Familiar with customer and regulatory audits for excipients and  pharmaceuticals, a plus.
• Internal Auditor certified.  (ie. ISO 19011)
• Intermediate computer literacy and software applications. Strong Computer skills of MS Office Suite, Quality Management Software (QMS) or Laboratory Management systems (LMS) systems. Experience in an ERP system, or Sharepoint software a plus.  This position involves creating company platforms within a variety of customer specific software and data processing systems.
• Proven Project Management skills.
• Able to present quality topics & learnings in large group settings.
• Proven technical writing skills and attention to detail in a scientific environment warranting such skills.
• Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
• Skilled at organizing information into a clear and concise written form.
• Ability to work independently as well as in a team environment.

Physical Requirements:

• Up to 20% of travel time.
• Position is in office setting, open environment.
• Activities can be routine, repetitive. Prolonged periods sitting at a desk and working on a computer.
• Ability to see and distinguish color.
• Lift up to 25 lbs. occasionally.
• Bend, stoop, carry.
• Repeating motion that may include wrists, hands, and fingers.

  PERFORMANCE MEASURES AND STANDARDS  

• Attention to detail and organization skills.
• Meet established deadlines internally and with customers.
• Must be able to work quickly with a high degree of accuracy.
• Proven, professional technical writing skills.
• Demonstrate strong planning skills and initiative to manage a fluctuating workload while supporting the Corporate QA team.
• Maintain and monitor the Customer database systems to review, complete, and close items on behalf of company within a timely manner.
• Maintain and monitor the company's Quality software database system (IQS) to review, approve and close items on behalf of Corporate Quality Assurance.
• Complete assigned audits and final reports in a timely manner.
• Ensures 100% compliance with the governmental and local regulations

• Arrange personnel coverage in the event of absence. 
• Provides documented communication with specified customers.
• Adhere to all Environmental, Health, Safety, Security Requirements covered under Local State and Federal Regulations.
• Follow all ISO 14001, ISO 9001 and HACCP guiding principles, policies, procedures, and other requirements.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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