Raland Compliance Partners provides compliance consultation and guidance for organizations in the pharmaceutical, biotech and medical device industries. In all GxP engagements, we strive for immediate and sustained process improvement, from product development to patient delivery.

RCA is a team of experienced professionals from FDA-regulated industries. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. Not only does RCA understand the complexities of running a life science business, we can also negotiate the difficult demands of remediation and compliance with insight, hindsight and the clear advantage of our unique expertise and experience.RCA brings full-spectrum solutions to compliance, regulatory, quality assurance, R&D and operational challenges for life science clients. RCA offers top-tier strategic planning, mid-level project management and hands-on support to provide a customized action plan to meet our clients’ needs, on time and on budget.

Raland Technologies, LLC and Compliance Partners, LLC have merged to form Raland Compliance Partners, LLC. Raland Compliance Partners (an Inc. 500|5000 Company) is a full-service GxP regulatory compliance consulting firm supporting product development from concept to commercialization. Focused on providing specialized training, regulatory, quality and integration services to companies from start-up thru commercialization. A team of highly seasoned experts, many of our associates have FDA service experience, and all are experienced in the technical and operational aspects of the pharmaceutical, biotech and medical device industries. Our deep knowledge and strategic insight enable us to skillfully apply solutions. Clinical Trail Support • Regulatory Affairs • Clinical Development • Quality Systems • Vendor Assessment • GCP and GLP Training Development and Delivery Pharmaceutical and Medical Device Manufacturing Support: • Clinical and Commercial Manufacturing Support • Formulation Development • Process Development • Supply Chain Management • Facility Design • Plant Controls and Automated Systems • Program Development • Procedures and Policies • Validation Master Planning • Facility, Utility & Equipment Commissioning/Qualification • Computer System Validation • Cleaning Validation • Method Validation • Process Validation Training and Translation Support: • Training Gap Analysis • Custom e-Learning Development • Instructor-led Training Materials Development • Webinar Development and Technical Support • Mobile Point-of-Need Content • Video Production and Post Production • Audio Engineering • Foreign Language Translation and Interpretation Services With headquarters in Rochester NY and offices in Chicago IL, Rockville MD, , Lake Havasu AZ, Cincinnati OH and Philadelphia PA, and clients and associates across the globe.

Oversee company operations such as, but not limited to:• Developed a Human Resource department from scratch and built it to an effective HR compliance program within 8 months.• Built and manage recruitment and sourcing of high level subject matter experts for FDA regulated clients worldwide• Negotiate consultant pay rates and client bill rates to maintain profit margin• Developed IT infrastructure for business to allow remote employees access to company electronic documents• Developed company website• Oversee accounting, client invoicing, collections• Project Management • Developed and maintain resource skillset matrix to match resources with specific opportunities• Conduct new employee orientations; administered pre-employment tests; conduct reference checks.

.• Oversee all facets of Compliance Staffing Inc.• Full P&L accountability of a multi-million dollar business including operational efficiency and process management• Effectively manage all areas to ensure profitable performance• Protect the assets of the company by adhering to safety, audit and Human Resource guidelines to ensure government regulation compliance.

Manager of Human Resources & Talent Acquisitions• Manage department in carrying out various human resources programs and procedures for all company employees. • Coach and advise executive management on hiring decisions, compensation, employment and labor laws• Created and managed the preparation of the performance review program• In charge of policy development and documentation• Develop strategies that increase employee engagement & retention• Manage compensation and benefits administration to include claims resolution, change reporting, and approving invoices for payment• Responsible for entire recruiting life cycle including needs assessments & forecasting• Lead the recruitment effort of hiring more than 100 resources within a four month period for a worldwide medical device client• Responsible for the recruitment of: Cleaning, Quality and Validation engineers, program directors, project manager, sterilization SME’s, aseptic SME’s, lean manufacturing and six sigma experts, materials experts, CQA auditors and other technical positions in the medical device, pharmaceutical and biotech industries• Lead recruitment effort for exempt and nonexempt personnel (including executive levels); coordinate the use of over 150 permanent and contract employees• Conduct new employee orientations; administered pre-employment tests; conduct reference checks. • Lead performance improvement discussions and terminations• Manage organizational training and development efforts• Employee relations and counseling• Manage $1MM budget.

• Managed the full life cycle recruitment process for all corporate positions for a client in the Gulf Coast which included: Lab Specialist, Executive Assistants, IT positions, Field Sales, Senior Director positions and more. • Assisted with the implementation and recruiting plans for Gulf Coast/South East Region clients.• Utilized low cost recruiting methods for all entry level to senior management positions, with no use of outside agencies• Wrote advertisements, analyzed resumes, established interviewing questions, screened candidates, administered assessments, negotiated offers, and conducted background checks • Conduct daily recruiting/interviewing calls using multiple networking strategies. Apply sound strong negotiation skills to incumbents• Source on all boards; attend job fairs• Lead recruiting meetings with hiring managers on all requirements understandings, candidate pipeline, and submissions to new creative sourcing strategies• Update ATS database daily

• Responsible for the recruitment of: Research and Development and Pharmaceutical Operations divisions, which include director and manager level positions such as engineers, Scientific, Marketing, scientist, chemist, pharmacologist, statisticians, project managers, Regulatory Affairs Associates, directors, publishes and more Clinical professionals; supporting and building quick rapport and relationships with senior level executive internal clients • Manage the full life cycle recruiting activities: visa processing, perform on-site competency interviews, provide input into the decision-making process to hire key candidates, and responsible for creating competitive offer packages• Maintain between 55 - 65 positions• Create staffing plans and regularly meet with clients to predict future open positions• Experienced with H1-B, TN-1 work visas• Work with other departments such as Sourcing, University Relations to create a candidate pipeline

• Manage the full life cycle recruiting activities, perform on-site competency interviews, provide input into the decision-making process to hire key candidates, and responsible for creating competitive offer packages• Responsible for approximately 130 temporaries on assignments at Abbott Laboratories in four divisions• Visited customers regularly to ensure they are satisfied with the candidates on their assignments. Job scoped and obtained detailed assignment information on positions available• Handled unemployment claims, and hearings

• Oversee high volume recruiting for industrial positions • Supervised over 250 temporary employees• Helped design and managed interview process including: scheduling, collection of timely feedback, and facilitated hiring decisions including conducting de-briefing sessions and coordinating offer letters • Enhanced and implemented an effective Employee Referral Program that increased candidate referral and reduced overall recruitment expenses • Monitored performance of temporaries• Managed the full life cycle of recruitment processes including: strategies, methods, sourcing, qualification, selection, pre-employment verification, offer letter preparation, and on-boarding • Collaborated with hiring managers as business partners to determine staffing needs, develop workforce plans, sourcing strategies, interview processes, selection criteria, and employee relation issues