28 days old

Quality Compliance Consultant (pharma)

Kelly Services
Coppell, TX 75099
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 7+ month, long term contract opportunity as a Deliver Compliance Specialist for a top fortune 500 company in Coppell, TX.

**Title:** Deliver Compliance Specialist

**Duration:** 7+ months

**Location:** Coppell, TX

**Essential Duties and Responsibilities:**

+ The Deliver Compliance Specialist is responsible for the oversight and execution of Quality and compliance programs.

+ The position serves as a single point of contact to quality and supply chain partners and the DELIVER lead on distribution quality related matters.

+ The position identifies opportunities to continuously improve quality compliance, cost and time factors, consistent with Enterprise, Sector and DELIVER business objectives; identifies significant business issues, prioritizes for action and leads improvement opportunities and problem solutions.

+ The Compliance Specialist coordinates and directs quality and compliance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

+ Drives innovation within functional area while ensuring functional initiatives are delivered in a compliant, cost efficient manner.

+ Ensures that new initiatives meet customer, quality, and regulatory requirements.

+ Provides interpretation of policies and regulations to unique site requirements and problems and acts as quality representative for management initiatives.

+ Oversight of process and systems related with cGMPs, Product handling and storage, quality investigations and managing partnerships with Franchises and Affiliates.

+ Serve as single point of contact to internal and external partners on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

+ Identify opportunities to continuously improve quality, cost and time factors, consistent with both Sector and DELIVER business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions in collaboration with other Distributions Centers. Plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

+ Responsible for Quality oversight in product receiving process within the DC as well as Quality oversight in disposition of damaged packages (incoming) according to procedures or predefined agreements with Source Co., Franchise, or Marketing Co.

+ Responsible for Quality oversight in the following: monitoring of product destruction process, quarantine and hold processes within the DC and in pick/pack/and ship operations, including trending of pick/pack/ and ship errors.

+ Responsible for ensuring returned product is dispositioned according to procedures.

+ Responsible for Quality review special inspection operations conducted within the DC.

+ Responsible for Quality Management of temperature-controlled facilities: responsible for ensuring compliance with monitoring of ambient environment (temperature and humidity as required). Responsible for the oversight for the identification of temperature control excursions occurring within the DC and for the oversight for the investigation of temperature control excursions and subsequent remediation activities within the DC.

+ Responsible for Quality management input on the Warehouse Management Systems; responsible for the oversight of records and document management. Responsible for providing input to the development of validation implementation.

+ Responsible for establishing or overseeing appropriate internal-external Quality Agreements.

+ Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventative actions, audits, and other documentation. Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures.

+ Evaluate overall compliance risk, recommend corrective actions and track progress.

+ Escalate all appropriate issues to CLC Quality and Compliance Manager.

+ Responsible for the management of all Health Authority inspections (e.g. FDA) conducted at the DC, including reviewing the preparation plan with on-site management.

+ Makes quality decisions based upon assessments of compliance risks balanced with the overall business needs.

+ Must be a strong leader to provide site leadership.

+ Develop new strategies for improving daily support of DC Quality and Compliance while also delivering enhanced solutions for customers needs.

+ The Deliver Compliance Specialist carries out managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems. Responsible for the overall direction, coordination, structure, and evaluation of DELIVER quality engineer.

+ When required manage contractor or consultant workforce when business need arises.

+ Responsible for communicating business related issues or opportunities to next management level

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

+ Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).


+ Strong knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485 and/or ERP systems are required.

+ Strong communication, teamwork, problem solving, decision-making, and root cause analysis skills are required. Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred.

+ Experience with Warehouse Management Systems is preferred.

+ Experience with Temperature Control Transportation is preferred

+ This position will require up to 20% travel.

**Education / Experience:**

+ A Bachelor's degree in engineering, scientific, technical scientific, or Quality Regulatory Compliance or related discipline.

+ A minimum of 5-10 years of experience in a highly regulated industry is required. QA/QC experience in the Medical Device, Pharmaceutical or consumer products industry and experience with regulatory inspections is preferred.

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( ) for immediate consideration.

**Why Kelly?**

+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-08-21 Expires: 2020-09-21

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Quality Compliance Consultant (pharma)

Kelly Services
Coppell, TX 75099

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