Administrative Assistant - Executive/CEO click here

JOB TITLE: Administrative Assistant DEPARTMENT: Executive/CEO

MAIN PURPOSE OF JOB: NeilMed Pharmaceuticals, Inc. is looking for an ambitious administrative assistant to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a “go-getter”, and highly motivated administrative assistant, who is interested in joining the industry leader of sinus rinse in the North Bay. Under general supervision, this position assists Company’s CEO, Executive Assistants, and possibly other administrative staff employees. The essential job functions are to perform a variety of clerical and administrative tasks.

JOB DUTIES/RESPONSIBILITIES: Clerical support to CEO’s assistants; Running personal errands for CEO and Executive staff; Coordination of company drivers for airport pick up of VIP’s; Back up support and assistance with event planning; Data entry into company databases; Filing; Taking messages and follow up calls; Set up of department meetings and taking meeting minutes; Calendaring events and meetings in Outlook; Typing correspondence letters, dictation, and memos; Mail processing and processing product sample requests; Assistance with travel arrangements; Special Projects; Typing memos, correspondence letters, filing, mailings, and other duties as assigned.

REQUIREMENTS KNOWLEDGE / EDUCATION: Bachelors degree preferred MS OFFICE (Outlook, Word, Excel, and PowerPoint) BILINGUAL in Spanish a PLUS!!! JOB EXPERIENCE: At least 5 years experience in an administrative capacity. SKILLS/COMPETENCIES: Must be proficient in use of general office equipment such as fax, scanning capabilities, copying, printers, conference media, and phones. Ability to type 60+ words per minute with accuracy. Ideal candidate will be enthusiastic, dynamic, detail oriented, and extremely organized. Ability to multi-task and flexible to changing priorities and deadlines. Effective communicator both verbal and written. Candidate MUST use good judgment, discretion, and have a high degree of professionalism. PHYSICAL REQUIREMENTS: Walking up and down stairs, bending, and standing for limited periods of time May be required to sit for long periods of time Extensive use of keyboard and phones May be required to lift to 25 lbs. COMPENSATION: Commensurate with experience. Email to jobs@neilmed.com with the subject line "Administrative Assistant - Executive/CEO"

Administrative Assistant - Quality click here

JOB TITLE: Administrative Assistant DEPARTMENT: Quality Assurance

MAIN PURPOSE OF JOB: NeilMed Pharmaceuticals, Inc. is looking for an ambitious administrative assistant to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a “go-getter,” and highly motivated administrative assistant, who is interested in joining the industry leader of sinus rinse in the North Bay. Under general supervision, this position assists Company’s VP of Quality/Regulatory/VP of Manufacturing and Engineers of the dept. The essential job functions are to perform a variety of clerical and administrative tasks.

JOB DUTIES/RESPONSIBILITIES: Preparation of regulatory compliance documents, obtaining approvals and signatures of regulatory documents. Correspondence and follow up with external regulatory agencies such as, FDA, TUV, etc. Set up of department meetings and taking meeting minutes. Calendaring and maintenance of VP of Quality/VP Manufacturing’s schedule. Assistance with travel arrangements. Running errands for quality department. Clerical support to Engineers. Special Projects. Typing memos, correspondence letters, filing, mailings, and other duties as assigned.

REQUIREMENTS KNOWLEDGE / EDUCATION: Bachelors degree preferred Regulatory/QA/Manufacturing/Engineering industry experience is a PLUS! MS OFFICE (Outlook, Word, Excel, and PowerPoint) JOB EXPERIENCE: At least 5 years experience in an administrative capacity. SKILLS/COMPETENCIES: Must be proficient in use of general office equipment such as fax, scanning capabilities, copying, printers, conference media, and phones. Ability to type 60+ words per minute with accuracy. Ideal candidate will be enthusiastic, dynamic, detail oriented, and extremely organized. Ability to multi-task and flexible to changing priorities and deadlines. Effective communicator both verbal and written. PHYSICAL REQUIREMENTS: Walking up and down stairs, bending, and standing for limited periods of time May be required to sit for long periods of time Extensive use of keyboard and phones May be required to lift to 25 lbs. COMPENSATION: Commensurate with experience. Email to jobs@neilmed.com with the subject line "Administrative Assistant - Quality"

QA Manager click here

JOB TITLE: QA MANAGER DEPARTMENT: QUALITY / REGULATORY REPORT TO: VP QA/RA

MAIN PURPOSE OF JOB: Develop, establish, and maintain quality assurance goals / objectives, policies, processes and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. May serve as a liaison between the company and various governmental agencies. Provide leadership for customer-focused quality, quality systems improvements, and business process improvement initiatives.

JOB DUTIES/RESPONSIBILITIES: Oversee generation and review of documents used in good manufacturing practices; monitor audits of production and quality control areas. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness. Work in close collaboration and partner with other functions, including manufacturing, Finance/IT, Human Resources, Regulatory, Supply Chain, Research & Development etc to optimize overall operational efficiency and effectiveness. Manage document control, and provide oversight of related quality systems such as training and other monitoring systems to ensure effectiveness. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations. Supervise workmanship and lead performance review of Quality employees Oversee nonconforming material control, CAPA, Planned deviation, Supplier Quality and data analysis related to yield, etc. Create a Monthly quality score card and present to management on a regular basis. Preparation of regulatory compliance documents, obtaining approvals and signatures of regulatory documents. Correspondence and follow up with external regulatory agencies such as, FDA, TUV, etc. Act as Management Representative for the company and lead management review, Internal and external audits. Generate and review of documents used through Quality system. Plan, coordinate and prepare document packages for regulatory submissions (if required), including FDA 510(k), Technical Files, Canadian Device License Applications, and internal "Letters to File". Support Regulatory submissions and on-going regulatory compliance for product development process. Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Review and sign off on product and manufacturing changes for compliance with applicable regulations. Review and approve regulatory submissions and approvals, including design and manufacturing changes and labeling. Review and approve test protocols to support regulatory submissions. Oversee Risk Management and provide input in design verification, design validation, shelf life studies. Develop and implement departmental and divisional policies and procedures. Other duties as assigned

REQUIREMENTS KNOWLEDGE / EDUCATION: Bachelor’s degree in a technical or scientific field, preferably engineering Comprehensive knowledge of GMP and ISO 13485:2003 regulations. JOB EXPERIENCE: Minimum of at least 5 years’ experience in quality for medical devices or a combination of medical device and pharmaceuticals Minimum 5 years’ management experience in a complex environment SKILLS/COMPETENCIES: Supervisory/management skills. Technical writing Excellent communication and presentations skills (articulate and persuasive) Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Ability to translate quality initiatives into specific objectives, metrics, and action plans Hard working and ability to work long hours and weekends if necessary DESIRED/PREFERRED QUALIFICATIONS Master’s degree in engineering or science Prior experience managing the quality system in a manufacturing environment Broad understanding of US and International regulations including 21 CFR, 820 Influence management skills; demonstrated ability to work constructively across all functions of the organization Experience presenting, interacting, and building effective relationships with regulatory agencies Willingness to “do what it takes,” including direct auditing activities at times Ability to attract, develop, and retain diverse talent Proven experience in achieving results through influence management and motivating teams PHYSICAL REQUIREMENTS: Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse May require domestic and international travel (10-20%) Email to jobs@neilmed.com with the subject line "QA MANAGER"

Purchasing Manager click here

JOB TITLE: Purchasing Manager DEPARTMENT: Operations REPORT TO: VP of Manufacturing

MAIN PURPOSE OF JOB: NeilMed Pharmaceuticals, Inc. is looking for an ambitious Purchasing Manager to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a “go-getter,” roll up the sleeves, hands on, and highly motivated individual who is interested in joining the industry leader of Saline, Nasal rinse solution, spray and gel products in the North Bay. Provide leadership of cross-functional teams and facilitate these teams in the development and execution of long-term strategies that will optimize NeilMed’s position in terms of quality, cycle/response time, risk, and total cost. Mitigate risk, leverage technology and purchase power, improve purchasing processes and systems, and reduce overall product cost. Negotiate, establish and monitor supplier agreements. Directs and coordinates activities in purchasing, and receiving raw materials and supplies in organization by performing the following duties.

JOB DUTIES/RESPONSIBILITIES: Lead cross-functional teams in the development and implementation of strategies and goals in support of business objectives for cycle/ response time, quality assurance, new product development, risk mitigation, and total cost. Strategies extended through full supply chain including primary and sub-tier suppliers. Negotiate types of agreements with suppliers including development, supply indemnification, etc. Monitor agreements and expectations. Lead efforts for supplier sourcing, qualifying, analysis and selection processes, make/buy, outsourcing, and transitions. Assists with special projects as required. Act as project manager in various types of continuation/ product support projects. Develop strong partnering relationships with Suppliers and Manufacturing Operations, Suppliers Quality Assurance, Product development and Finance department to accomplish strategic objectives. Suggest and implement appropriate business strategy changes in purchasing department. Develop technology roadmaps and corresponding supplier roadmaps where needed. Ensure personal understanding of all quality policy/system items that are applicable to Purchasing department. Follow all work/quality procedures to ensure quality system compliance and high quality work. Responsible for supplier negotiations, purchases, and administrative duties (including contracts) involved in the procurement of all raw materials and shop supplies. Reviews planning parameters, current on hand, open work orders and sales orders to ensure constant supply of materials while reducing overall inventory levels. Maintains and keeps accurate all purchase order data inputs in ERP system. Continuously address and reduce slow moving and obsolete inventory. Arranges for disposal of surplus materials Conducts regular cycle counts, identifies & resolves cycle count issues Organizes & Implements annual physical inventory, identifying & resolving variances. Prepares and issues purchase orders and change notices. Participates in continuous improvement processes as appropriate to support company goals & profitability. Stays current with new materials & technologies relevant to industry, identifying and recommending opportunities to improve quality, provide competitive differentiation, and improve profitability. Carries out managerial responsibilities in accordance with company policies and applicable law that include safety, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Ensures a clean and safe work environment at all times and adheres to all plant safety rules and policies. Other duties as assigned

REQUIREMENTS KNOWLEDGE / EDUCATION: Bachelors degree preferred Certified Purchasing Professional designation an asset JOB EXPERIENCE: 5-7 years related experience in Supply Chain positions including team leadership, strategy development, contract development and execution. Experience providing direction to others. SKILLS/COMPETENCIES: Previous buying experience in high-volume, low-tech manufacturing industry Experience with manufacturing processes and machinery Strong negotiation skills Effective communication and relationship-building skills Good customer focus Excellent communication skills (both verbal and written) Computer literacy and proficiency with MS Office and MS Project PHYSICAL REQUIREMENTS: Walking up and down stairs, bending, and standing for limited periods of time May be required to sit for long periods of time Extensive use of keyboard and phones May be required to lift to 25 lbs. COMPENSATION: Commensurate with experience. Email to jobs@neilmed.com with the subject line "Purchasing Manager"

Office/Facilities Manager click here

JOB TITLE: Office/Facilities Manager DEPARTMENT: Administrative REPORT TO: Controller

MAIN PURPOSE OF JOB: NeilMed Pharmaceuticals, Inc. is looking for an ambitious Office/Facilities Manager to join our Santa Rosa Corporate Headquarters. This is a fantastic opportunity for a “go-getter,” roll up the sleeves, hands on, and highly motivated individual who is interested in joining the industry leader of sinus rinse in the North Bay. Under general supervision, this position manages the day to day facilities and operations of the corporate office.

JOB DUTIES/RESPONSIBILITIES: Manages day to day office operations Manages office lease, office equipment, and associated agreements/service contracts Manages administrative office facilities including office moves, furniture, janitorial, safety, etc and associated vendors Maintains office supplies and office equipment Manages Information Technology activities working concurrently with third party IT Company Manages the administrative department with staff scheduling, including time off requests ensuring department coverage during work hours Maintenance of common areas such as, the break rooms, conference rooms, and lobby. Manages and coordinates facility activities, general repairs, office moves and other related matters. Serves as a point of contact for property management and office improvements Serves as a point of contact for service vendors (examples: cleaning services, alarm system, repairs, etc.) Support's IT with special projects.

REQUIREMENTS KNOWLEDGE / EDUCATION: Bachelors degree preferred Advanced Computer and Office equipment expertise Information Technology experience background helpful MS OFFICE BILINGUAL in Spanish a PLUS!!! JOB EXPERIENCE: At least 8-10 years related experience in Facilities/Office Management capacity. SKILLS/COMPETENCIES: Must have advanced proficiency with use of general office equipment such as fax, scanning capabilities, copying, printers, conference media, and phone systems Must have clear understanding of IT systems Supervisory experience Ideal candidate will be enthusiastic, dynamic, detail oriented, and extremely organized Ability to multi-task and flexible to changing priorities and deadlines Must have advanced communication skills both verbal and written Candidate MUST use good judgment, discretion, and have a high degree of professionalism. PHYSICAL REQUIREMENTS: Walking up and down stairs, bending, and standing for limited periods of time. Extensive use of keyboard and phones. May be required to lift to 25 lbs. COMPENSATION: Commensurate with experience. Email to jobs@neilmed.com with the subject line "Office/Facilities Manager"