PittsburghRecruiter Since 2001
the smart solution for Pittsburgh jobs

GxP Auditor/ Compliance Specialist (Pharmaceutical Industry)

Company: MMS Holdings Inc.
Location: Pittsburgh
Posted on: September 9, 2019

Job Description:

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.Roles & ResponsibilitiesPlan, prepare and conduct GxP audits, including investigator site, process, quality system, computer system, vendor qualification audits and other types of clinical trial and pharmaceutical-related audits as required, under direct supervision of the Project LeadParticipate in the development Corrective and Preventive Action (CAPA) plans, and contribute to resolution of audit findings, under direct supervision of the Project LeadDraft audit plans, reports and other required audit documentation, under direct supervision of the Project Lead. Coordinate internal and external reviews and finalize documents according to project timelinesAssist with internal quality assurance (QA) audits (including document and process audits) per procedure, as needed under the direct supervision of MMS QADevelop and maintain SOPs, work practices, forms and other documentation and training materials related to GxP compliance and auditing servicesDevelop quality-related documentation for client projects, including SOPs, work practices, forms, training materials, etc., under the direct supervision of the Project LeadAssist with project management activities associated with auditing projects, including maintenance of project informationAssist with oversight of vendor monitoring services to ensure processes are followed and quality is maintainedObserve and adhere to applicable regulatory and legal requirements, including participation in impact assessments for MMS/clients for any regulatory updatesPerform Quality Control (QC) of scientific documents and reports, as requestedInteract directly and with clients and demonstrate strong client interaction skillsParticipate in company and departmental process improvement and recommend suggestions to improve efficienciesRepresent self and company in a professional manner and in line with core company valuesPractice excellent internal and external customer service, communication, and team workSupport objectives and improvement efforts within department and organizationallyComply with all applicable policies, procedures, and training requirementsRequirementsBachelor's degree in biomedical, nursing or related life science discipline required2 years of related experience or relevant pharmaceutical, health authority and/or CRO experience, prior experience in a Quality Assurance department or GxP auditing role preferredExperience leading independent audits is requiredFamiliarity with ISO 9001:2015 and ISO 27001:2013 standards and requirementsFamiliarity with 21 CFR Part 11, FDA, and GCP requirementsKnowledge of drug development processes with the ability to apply drug development knowledge during GxP audits and process evaluationsKnowledge of GxP guidelines as well as applicable government regulations related to pharmaceutical product development and clinical trial regulationUnderstanding of scientific, medical, and/ or clinical dataExcellent, demonstrated verbal and written communication skillsWorking knowledge of QC practicesProficient with MS Office applicationsAbility to travel up both domestically and internationally up to 50% to complete onsite audits Excellent organizational and communication skills and detail-orientedbwXLx7ksyO

Keywords: MMS Holdings Inc., Pittsburgh , GxP Auditor/ Compliance Specialist (Pharmaceutical Industry), Other , Pittsburgh, Pennsylvania

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Retail Store Shopper and Delivery Driver
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Akron
Posted on: 09/20/2019

Escrow Loan Closer
Description: Description Prepare closing disclosures in conjunction with the mortgage loan closer. Ensure that all fees are correct
Company: Huntington National Bank
Location: Akron
Posted on: 09/20/2019

Administrative Assistant Account Coordinator
Description: Premier Finance Adjusters is seeking an Administrative Assistant Account Coordinator to join our team As an Administrative Assistant Account Coordinator, you will be responsible for responding (more...)
Company: Premier Finance Adjusters, Pittsburgh PA
Location: Pittsburgh
Posted on: 09/20/2019


Acute Licensed Practical Nurse LPN
Description: We are teammates. Have a dramatic impact on patients and their families by ensuring the compassionate, professional delivery of all dialysis-related nursing services in an outpatient setting. You will (more...)
Company: DaVita
Location: Akron
Posted on: 09/20/2019

Food Runner (Part-Time) AM/PM Flex Schedule - The Ritz-Carlton - (19089389)
Description: Food Runner Part-Time AM/PM Flex Schedule At more than 80 award-winning properties worldwide, The Ritz-Carlton Ladies and Gentlemen create experiences so exceptional that long after a guest stays with (more...)
Company: Marriott International, Inc.
Location: Akron
Posted on: 09/20/2019

Delivery Driver - Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Akron
Posted on: 09/20/2019

Class A Truck Driver - Great Pay!
Description: The Pay Competitive Pay and Regular Home Time Pay based on driving experience Bonuses Bonuses for Safety, Miles and Fuel The Benefits Low-Cost Health
Company: Doug Andrus
Location: Akron
Posted on: 09/20/2019

Supermarket Shopper
Description: Every few years, a company emerges and transforms an industry. Instacart been leading the evolution of a 800B retail market, and redefining how people shop for groceries. In a few short years we've launched (more...)
Company: Instacart
Location: Pittsburgh
Posted on: 09/20/2019

Set Your Own Schedule - Shop and Deliver Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Akron
Posted on: 09/20/2019

Part-time Shopper
Description: Every few years, a company emerges and transforms an industry. Instacart been leading the evolution of a 800B retail market, and redefining how people shop for groceries. In a few short years we've launched (more...)
Company: Instacart
Location: Pittsburgh
Posted on: 09/20/2019

Log In or Create An Account

Get the latest Pennsylvania jobs by following @recnetPA on Twitter!

Pittsburgh RSS job feeds