9 days old

Quality Specialist / Deviation Investigator

Kelly Services
Malvern, PA 19355
Full-Time - Hybrid Remote

Kelly Engineering is hiring a Quality Specialist / Deviation Investigator for an opportunity with one of our global pharmaceutical clients to work in Malvern PA.

This is a great way to gain industry name experience and grow your science and chemistry career! Work directly with ground-breaking drugs helping save lives day after day.

**Job Description**

As a Quality Specialist, you are a technical expert supporting the manufacturing of biological products. You will provide technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations. You will monitor and trend key process parameters. You will troubleshoot manufacturing problems as required and provide primary technical support. You will identify and implement process improvements both locally and across the network. You will support capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. You will conduct technical and validation studies.

**Key Responsibilities**

+ Provide primary production support and technical support for the investigation and resolution of deviations and atypical events under the direction of a specialist.

+ Partner with primary investigator / Specialist to ensure consistent quality standards are maintained.

+ Help identify true root cause of investigations, assess product quality impact, and approve investigations as management technical representative, as needed.

+ Recommend, own and implement corrective/preventative measures aimed at improving compliance and reducing repeat occurrences, following up to determine if corrective actions adequately addressed root cause of NC event.

+ Track deviations, events and key process parameters and provide reports to management on trending, and status as requested, recommending corrective actions for any trends identified, and collaborate with management to review and approve events and deviations

+ Act as a SME to customers, providing guidance on deviations, investigations, and issues pertaining to quality of product.

+ Identify and implement process improvements within the change control system and related to safety, environmental, quality, compliance, productivity, yield, and cost, partnering with all Cells and COEs as applicable.

+ Develop business cases for projects and present to site leadership for approval.

+ Initiate and execute change controls for projects and work with management to allocate group resources to assist with change control, equipment startup, and technical training, assuring regulatory compliance and technical feasibility of proposed changes.

+ Serve as project manager for the change process and provide coordination to ensure timely and compliant implementation of process improvements.

+ Share best practices between production sites and assist with equipment startup and technical training as required.

+ Provide technical support concerning the change control system and for process and cleaning validation maintenance and verification and assist with cleaning cycle optimization and revalidation efforts.

+ Serve as a SME during internal and external regulatory audits including FDA, EMA.

+ Extract process data from SCADA and Delta-V servers for use in databases maintained by technical operations and utilize database to monitor process performance and proactively troubleshoot operations.

+ Work with Automation and Information Management to improve the effectiveness of process data collection and analysis.

+ Coordinate data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database SQC and the Annual Product Review APR.

+ Demonstrate expertise in several the following areas: cGMPs, FDA regulations, cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities.

+ Provide documentation support for SOP/ Batch Record revisions, identify, and communicate necessary document changes to document management group to ensure timely revision to all SOP and batch records and review and approve SOP and Batch record revisions.


+ Minimum Bachelors degree required; focused degree in technical area preferred

+ Minimum 1 year of related work experience required

+ Requires experience in a manufacturing environment, biopharmaceutical, or pharmaceutical industry

+ Ability to interpret and carry out a variety of technical or other instructions furnished in written, oral, mathematical, diagram or schedule form or other nonverbal symbolism (formulas, scientific equations, graphs, etc.)

+ Ability to apply principles of logic or scientific thinking to define and deal with intellectual and practical problems, involving abstract and concrete variables in standardized situations, and collect data, establish facts, and draw valid conclusions

+ Ability to make innovation part of the site agenda and be an active driver of innovation, thinking outside of the box and challenging others to do the same

+ Experience training or mentoring others is preferred

+ Compliance experience preferred, including adherence to local, state, and federal regulations and guidelines (EPA, OSHA, etc.); cGMP or FDA is helpful

+ Expertise in one or more of the following areas preferred: cell banking, formulations, Cell culture, chromatographic purification, ultrafiltration, microfiltration, diafiltration, viral inactivation, filter integrity testing, CIP/SIP systems, or pharmaceutical water systems and utilities

+ Experience preferred supporting or conducting investigations or audits

+ Lean, Six Sigma, or Process Excellence experience or certification preferred

+ Project management experience or certification preferred, capital project experience helpful

+ Familiarity with SAP, TrackWise, LIMS is helpful

+ Requires the flexibility to perform off-shift work routinely and on-call support on a rotational basis to support a 24/7 facility

+ Requires mobility to independently transport oneself between various sites/locations, as necessitated by the essential functions and responsibilities of the position

+ Ability to perform gowning procedures to work in manufacturing core is required

+ Location & Travel Required: Malvern, PA and up to 10% domestic and international travel

**Send resumes to**

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

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**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 (plus, did we mention we provide a ton of benefits ?). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2022-05-09 Expires: 2022-06-09

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Quality Specialist / Deviation Investigator

Kelly Services
Malvern, PA 19355

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