Quality Assurance Specialist Jobs

Job Title: Biomedical Quality Assurance Manager Company: Aegis Worldwide Location: Cincinnati, OH Description: A global medical device company, Headquartered in Cincinnati, OH, is currently looking for a QA Manager for their Diagnostics division.   The QA Manager will be responsible for all Quality Assurance aspects of the quality system are complete, including auditing, trend analysis, complaint review, and document review, and investigating noncomformities.  Direct CAPA reports. Requirements Qualifications: (Education/Training/Experience) -BS degree in a biological science or related field preferred -Working knowledge of federal regulations, ISO standards, OSHA regulations -In-vitro experience preferred -Previous supervisory experience in Quality Assurance

Job Title: Pharmaceutical QA Compliance Specialist Company: Indevus Pharmaceuticals, Inc. Location: Cranbury, NJ Description: Primary responsibilities include internal/external auditing, monitoring vendor compliance, supporting the vendor qualification program, tracking compliance related commitments, conducting training as needed and authoring/revising quality system documents as needed.  Job Details:·         Develop and execute compliance procedures, independently execute internal and external quality audits in conformance with FDA, cGMP regulations and company procedures·         Audits include our GMP manufacturing facility, suppliers/vendors, and contract manufacturers·         Monitor action plans in response to any regulatory agency or internal audits/inspections to assure timely completion·         Assist in conducting in-plant training for new and existing employees including orientation, cGMP training, and awareness of regulatory and quality policies/procedures and industry compliance topics·         Provide regulatory/compliance expertise and interpretation to personnel or situations requiring such expertise·         Support vendor/supplier qualification and acceptance program·         Maintain up-to-date knowledge of regulation, standards and policy·         Provide documentation, investigation, change management support etc, to other departments as needed·         Provide support to QA department activities as needed·         Travel required (approx. 25%)  Qualifications & Experience:·         3+ years of pharmaceutical/biotechnology external auditing, CQA preferred·         Associate or Bachelors degree in scientific or related discipline preferred·         Ability to multi task and continue forward progress with projects under minimal supervision in a fast paced environment·         Demonstrated interpersonal / communication skills·         Ability to effectively interface at all levels of the organization, with external contacts, and with cross-functional teams·         Must be able to give direction and training to others·         Must be able to plan, organize and execute role in an effective manner·         Ability to utilize Microsoft Office

Job Title: Healthcare Compliance Specialist Company: MRINetwork Location: Cambridge, MA Description: ABOUT USManagement Recruiters International Inc. (MRINetwork) is the world's largest executive search and recruitment organization with a global network of more than 1,100 offices and 4,500 recruiting professionals.  Founded in 1966 and consisting of five offices across New England, The Boston Group is MRI’s oldest, largest, and most highly acclaimed member. COMPANY INFOOur Client is a Boston Area biopharmaceutical company whose mission is to develop ground breaking products to combat devastating illnesses and enrich the lives of patients. JOB DESCRIPTIONThe function of the Healthcare Compliance Specialist is to make certain that the Company adheres to various protocols as they relate to legal and ethical business standards.  The Specialist will be an instrumental component of the Company’s Senior Management Team.  He/She will adhere to the Corporate Integrity Agreements and advance/implement the Company’s compliance program.  The Specialist will review, investigate, audit and monitor issues regarding compliance, and be an innovative implementer and trainer of compliance and risk reduction programs for the sales team.    QUALIFICATIONSJ.D. preferred.  Bachelor’s required. Experienced pharmaceutical compliance specialist. Working knowledge of regulatory issues is desirable.  At least 10 years of experience, in compliance program creation and implementation. Proven track record as an attorney in the healthcare sector may be substituted for a background in the compliance field. In addition, the successful candidate should have knowledge of: Federal Sentencing Guidelines (Compliance Programs) Anti-Kickback Statutes The False Claims Act FDA Regulations for the promotion of pharmaceuticals.The successful candidate should be an inventive team builder with the ability to effectively analyze and resolve matters.   Integrity and a passion to promote and promulgate the ethical standards of the Company are mandatory.   Keywords:  J.D., Legal, Attorney, Lawyer, In House Counsel, Corporate Counsel, Regulatory Affairs, Compliance, Biotechnology, Biomedical, Pharmaceutical, Clinical Trials, Non-Clinical Trials, Licensing, Biologics, Life Sciences, Medical Devices, FDA, Anti-Kickback, Corporate Integrity Agreements, False Claims Act, Federal Sentencing Guidelines Qualified candidates please submit your resume as an MS Word attachment to Charles J. Saia, Esquire: Register to View -boston.com .  Due to the large volume of resumes received only candidates with specific qualifications requested by our client will be contacted.

Job Title: Product Compliance Specialist Company: Rust-Oleum Location: East Millstone, NJ Description: Product Compliance Specialist For over 75 years RustOleum has been a world wide leader in protective paints and coatings for both home and industry. Vital to the success and growth of our company is a strong commitment to our customers and employees. RustOleum is currently seeking a Product Compliance Specialist to join our Technical department at our facility in Somerset, NJ.  The main responsibilities of this position will be to ensure product safety compliance while maintaining existing and new MSDS files.   Responsibilities Coordinate and review MSDS process Review copy of product labels and customer communications regarding product regulationsCreate formula breakouts which are used for MSDS updates and product labelsReview incoming new raw materials MSDSCoordinate consumer safety testing of Zinsser productsOptiva or Product Vision regulatory module development and implementationDevelop/revise product MSDSsDevelop/revise product precautionary labeling according to Federal, State and local regulationEnsure compliance with Company standards throughout the product development process Requirements Bachelors degree in biology, chemistry, or chemical engineering3-5 years working in an industrial environmentExperience in safety management and product stewardship Strong product safety background(labeling and MSDS)Hazardous material experience Understanding of manufacturing processes and chemistries employed by Zinsser and regulatory implications of marketing such products Strong presentation and written communication skills Ability to understand and interpret government regulations(NJRTK, Cal-Prop 65, etc.) and labeling regulationsKnowledge of coatings or polymer chemistry preferredWorking knowledge of Excel and Access Click Here to Apply Online

Job Title: DEA Regulatory Compliance Specialist (291554-551) Company: Cambrex Corporation Location: Charles City, IA Description: Company Information Take charge of your career and grow in new directions by exploring opportunities within a growing Life Sciences Company... Cambrex Charles City, Inc. is a subsidiary of Cambrex Corporation (NYSE: CBM). Headquartered in East Rutherford, NJ. Cambrex Corporation provides products and services to accelerate the development and commercialization of branded and generic small molecule therapeutics. Cambrex supports its customers worldwide with R&D and cGMP manufacturing facilities in the US and Europe, maintains an excellent regulatory compliance record and provides strong expertise in various chemical technologies. Cambrex Charles City, Inc. develops and manufactures active pharmaceutical ingredients and pharmaceutical intermediates for a wide range of applications.We are seeking a DEA Regulatory Compliance Specialist to work in our Charles City, IA location who shares the values and principles that characterize who we are and how we work. It's time to join our world-class team, if the following attributes reflect your desire to contribute: Innovation - Cambrex employees have a strong desire to excel and apply their skills in innovative ways to meet the demands of an ever-changing business environment. Experience - Cambrex employees provide knowledge-based solutions and are empowered to make appropriate decisions, and demonstrate a commitment to quality in everything they do. Performance - Cambrex is an organization that appreciates and rewards, efficient, reliable performance, meets goals and objectives, and delivers the Cambrex promise to bring value to our customers and investors with uncompromising integrity and ethics. Job DescriptionReporting directly to the Director, Regulatory Affairs, the DEA Regulatory Compliance Specialist will be responsible for overall DEA compliance with regulations and associated manufacturing requirements. The incumbent will monitor day to day operations related to controlled substances (CS) and maintain CS records as required. Job Responsibilities Responsibilities include, but are not limited to: Maintain accurate and complete registrations with the DEA Complete and file ARCOS quarterly and year end reports Act as point person for interactions with the DEA and act as Company liaison during on-site DEA audits. Maintain CS and listed chemical files, including documentation pertaining to shipping, receiving, 222 forms, ARCOS reports and correspondence with the DEA and other regulatory agencies as needed Maintain accurate records and correspondence related to manufacture and destruction of CS Complete, reconcile and report CS and listed chemical inventories Provide guidance and instructions to all internal departments with CS related issues and needs Prepare, conduct and maintain accurate employee training in compliance with site SOPs and government regulations Work with Sales and Marketing and customers to obtain appropriate volumen requests for CS quota Oversee shipment of CS from Cambrex to appropriate destinations. Job Qualifications BS/BA. Science or technical degree preferred - Chemistry, Biochemistry, Biology, Engineering 3 or more years of experience in a manufacturing or laboratory environment desired. Previous DEA or agency regulatory experience highly beneficial and desired Advanced written and oral communication skills required. Ability to communicate with multiple audiences including customers, regulatory agencies and internal employees a must. Advanced working knowledge of a computer applications within a Windows-based environment is beneficial Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Relocation assistance will be offered for this position. Post offer physical and drug screen are required. Interested candidates should submit a resume and cover letter with salary requirements to Human Resources, Cambrex Charles City, Inc.: online: www.cambrex.com or via fax: Register to View Thank you for your interest in Cambrex Charles City! Agencies should not forward resumes to Cambrex through this source. Cambrex will not be responsible for any fees arising from the use of resumes through this source. Equal Opportunity Employer M/F/D/V. Key Words: DEAcontrolled substancesregulatorymanufacturing

Job Title: QA Lot Review and Compliance Specialist, Biologics Company: Laguna Source Location: Boston, MA Description: QA Lot Review and Compliance Specialist, Biologics Manufacturing - New EnglandThis is a stellar opportunity responsible for  leading a broad set of QA activities within a leading BioPharma biologics manufacturing facility.  Your overall Quality Assurance responsibilities will include:* Providing Quality Assurance oversite & lot review of cGMP manufacturing batch records, quality control records, SOPs, protocols, and QC test data to ensure cGMP compliance, accuracy, and clarity. * Providing oversight and assurance that cGMP documentation meets FDA regulatory and interal quality requirements.* Implementing Quality Assurance activities involving large scale upstream mammalian cell culture and downstream protein purification processes.* Managing document control and change control processes.* Performing document review and approval for Process Validation, Equipment Validation, Computer Validation, and Analytical Methods Validation activities.* Overseeing Quality Systems involving Process Validation, Deviation Investigations, Statistical Process Control/SPC, and other Manufacturing Support activities. * Leading and developing document management and Corrective Action/Preventative Action (CAPA) systems.* Leading internal audits, external audits and FDA inspections. * Leading and managing cGMP/GMP documentation activities.Preferred Candidate Background and Expertise: * 5+ years Biopharmaceutical or Biotechnology industry experience. * BS or MS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Chemical Engineering, Biology or related life sciences field. MBA a plus. * Experience developing and implementing Quality Systems within a biologics manufacturing facility.* Experience developing and implementing Quality Systems for the manufacturing of biologics, monoclonal antibodies, recombinant proteins, or microbial derived therapeutics. * Expertise working within a manufacturing facility producing biologic products utilizing upstream mammalian cell culture and downstream protein purification processes.* Quality Assurance experiences involving the lot review of manufacturing batch records, quality control records, SOPs, protocols, and QC test data.* Experience leading internal audits, external audits and inspections. * Strong experience ensuring cGMP compliance and working with the FDA.For immediate confidential consideration, please email your resume directly to Jeff Schwartzman - Register to View