Abington, PA Classifieds > Jobs > Management

ed audits and ensures that their own work, as well as any employee supervised, is in compliance with established qualifications. Leading or supporting various regular audits or special audit investigations Working closely with other members within RCA or other audit groups for audit planning, risk assessment, reviewing audit fieldworks, audit reporting, or conducting audit tests as required Con...

ared Services FIS HM and Web Services across the enterprise. Future scope could increase to include additional applications such as Encore, Pega, and Filenet. p pp pJob Description p p Define and maintain the portfolio level Release plans, cross projectcross Release dependencies. p p Define and maintain the inventory for dependant trackedmonitored projects. p p Work with Application Teams, Rele...

improving plant operations and solving maintenance-related problemsbr four Ensure that maintenance technicians are adequately trained, equipped and motivated so that the maintenance program can be accomplished in a safe, timely and cost-effective mannerbr five Direct, maintain and enforce safety programs for the Maintenance Departmentbr six Ensure compliance with regulatory agencies and company...

g and diverse regulated environment.p p4 Head the quality organization that oversees GMP, GLP and GCP regulatory compliance for specified products, working with both direct and indirect reports across the organization.p p5 Includes process and analytical method development and validation activities, manufacturing of API and drug products, packaging and distribution of clinical supplies, oversig...

ess units in the resolution of quality-related issues stemming from the CAPA and internal audit programsp p4 Perform supplier audits, produce supplier audit reports and work with suppliers and business unit teammates to improve supplier quality and resolve supplier quality issuesp p5 Lead supplier CAPA activities and act as a quality liaison with suppliers and customersp p6 Manage companys CAPA...

irs strategy pertaining to all relevant company goals and objectivesbr three Direct domestic and global regulatory projects, determine submission qualifications, plan submission process and work with cross functional team to coordinate and approve regulatory documentation for inclusion in US and global regulatory submissionsbr four Perform regulatory review of manufacturing, quality, research a...

affairs management. Your specific areas of responsibility will includebr br one Act as the primary interface between the companys internal and external partner Q-Screen development teams and appropriate regulatory bodies, in particular the FDAbr two Provide regulatory guidance to the appropriate teams and develop and execute a plan for successful regulatory submissions for the Q-Screen instrume...

fication and ensure that technical problems are resolved on a timely basisbr four Ensure compliance with project scope, schedule and specificationsbr five Work with the Project Communications Manager to coordinate building access for sub-trades with the clientbr six Prepare documentation of schedules using MS Projectbr More questions Want to know the Compensation range Keep reading. br br The b...

and discipline employees, address complaints and resolve problems three Inspect products to verify conformance to specifications four Direct setup and adjustments of machines 5 Study production schedules and estimate worker hour requirements for completion of job assignment six Interpret company policies to workers and enforce safety and Good Manufacturing Practices regulations seven Interpret ...

mmon understanding of the future direction four Implement company policies within the region five Ensure all capital expenditures are in budget six Hire, evaluate middle management staff seven Oversee sanitation and quality control eight Ensure compliance with regulatory requirements, safety and customer relations nine Interact effectively with diverse workforcebr More questions Want to know th...

y officers and senior staff members in the implementation and execution of day-to-day planning, policies, programs and objectives three Develop the manufacturing and packaging plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards four Ensure employee staffing for plant operat...

mission and core values of the company are put into practicep p4 Foster a success-oriented environment within the company holding hisher self and others to highest ethical standardsp p5 Drive the company to achieve and surpass sales, profitability, cash flow and business goals and objectivesp p6 Spearhead the development, communication and implementation of effective growth strategies and proce...

duties, reorganizing workflow, relocating workstations equipment and purchase of new equipmenttechnology three Supervise Process Engineering Department four Collaborate with Production to modify workflow barriers and arrangements in order to increase throughput 5 Evaluate personnel skills and recommend employee placement to provide more effective operations six Recognize and resolve process flo...

ts, info amendments, etc four Ensure submissions adhere to FDA and ICH guidelines 5 Ensure submission process and standards adhere to company SOPs six Interact with clients regarding regulatory issues seven Conduct regulatory reviews for eCTDelectronic submission qualifications eight Contribute to company initiated project teams in fulfilling corporate objectives as determined by RA management ...

cations with clients, teammates and managers four Ensure that projects remain on schedule and within budget, are adequately staffed with personnel and resources and meet high-quality standards five Work together with staff members both intra- and inter-departmentally six Promote operational efficiency, teamwork and high morale seven Identify issues and develop strategies for ensuring study time...

ional project teams to deliver a high quality clinical trial or suite of clinical trials four Drive all aspects of the project management process from initiation, planning, execution, control to closure five Plandirect timelines as well as create and manage project budgets six Deliver projects on time and within budget seven Work with functional areas on initiating, planning, executing, control...

ich meet customers needs and established financial benchmarks four Direct manufacturing personnel to establish and adhere to production schedules to meet customer qualifications for quality, quantity and on time delivery of product 5 Develop and refine manufacturing processes and procedures to reduce cost, improve quality and ensure on-time delivery of salivary immunoassay products six Oversee ...

ks, state licenses, regulatory submissions and annual reports three Interact and maintain a dialogue with all relevant regulatory services in connection with regulatory submissions four Develop and maintain solid working relationships with dealers, distributors and regional sales leaders to help facilitate licensing, effective complaint handlingreporting, recalls, withdrawals and notifications ...

Partial Job summary one Conduct regulatory reviews of technical summaries, clinical study reports and administrative documents for regulatory filings two Assist with the filings and approval processes for IND, NDA, BLA and ANDA products three Compile IND maintenance submissions annual reports, info amendments, etc. four Ensure submissions adhere to FDA and ICH guidelines five Ensure submission ...

electronic publishing and web-basedelectronic clinical trial systemsp p3 Ensure for all in-house regulatory aspects of the clinical studies being performed by company as they relate to the development of medical devicesp p4 Ensure for maintaining quality and ensure that studies, documents and submissions to the federal agencies meet required industry and federally specified standards Good Clini...