Quality Assurance Compliance Coordinator

Kelly Science, Engineering, Technology & Telecom; Cincinnati (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading recruitment firm in Ohio is seeking a Senior Quality Assurance Coordinator to ensure compliance with regulatory requirements in the pharmaceutical industry. The successful candidate will manage customer documentation and assist in internal and external audits while showing great attention to detail. This position requires a Bachelor's degree and at least four years of related experience in a GMP environment. Strong skills in document control and quality management systems are also necessary for success.

Qualifications

• At least 4 years of progressive experience in a GMP manufacturing environment.
• Experience as a Quality Assurance Auditor with knowledge of GDP requirements.
• Certified Internal Auditor, e.g., ISO 19011.

Responsibilities

• Complete customer quality documentation for site and product qualification.
• Create and edit product documents and quality agreements.
• Support Customer QA with complaints and investigations.
• Manage electronic filing systems and customer specifications.

Skills

Attention to Detail

Organizational skills

Good communication skills

Self-motivation

Critical thinking

Teamwork

Determination

Education

Bachelor’s degree or related discipline

Tools

MS Office Suite

Quality Management Software (QMS)

Laboratory Management Systems (LMS)

ERP systems

Sharepoint software

Job description

Kelly Science & Clinical is seeking a Senior Quality Assurance Coordinator near Cincinnati, OH.

Direct Hire

Shift: Monday - Friday 8am-5pm

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.
• Self-motivation, initiative
• Critical thinking.
• Working well independently as well as in a team.
• Determination and persistence.

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.
• 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.
• 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.