CGMP Facility Manager

Full time
Albany, NY
Posted 1 year ago
Requirements :
This position requires extensive supervisory responsibilities. Personnel that report to the facility Manager may include: Pharmacists, chemists, QAO, Lab Assistants and technicians , Shipping Supervisors, Production Managers, Quality Control Specialists/Managers/Technicians, and Administrative Assistants. Qualifications | Education and/or Experience | • B.S. degree in Pharmacy or PharmD , chemistry or life science • 3 + years of well rounded business management experience. • Must be able to read, write, and speak English. • Knowledge of GMP practices and procedures. Language Skills | Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public. Mathematical Skills | Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations. Reasoning Ability | Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Computer Skills | Windows 98 or above Internet experience Familiarity with the following Microsoft programs is preferred: • Outlook • Power Point • Excel • Word • Access Word processing, spreadsheet, database, and e-mail software Basic knowledge of computer hardware, operating systems, and a wide variety of software applications (Preferred) Certificates, Licenses, Registrations | • As determined. Behavioral Characteristics | Individual must be detailed oriented, accountable, patient, and must be able to work in a team environment with minimum supervision. Individual must be capable of learning and understanding multiple disciplines while multi tasking. Must also have well-rounded management experience and have strong interpersonal communication and presentation skills. Must be a facilitator, decision maker, motivator, quick learner, and possess a team attitude while interacting with all levels of personnel. Physical Demands | The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to remain seated for extended periods of time. Ability to use hands to finger, handle, or feel in using office equipment, including the computer system for extended periods of time. Ability to talk and hear to conduct frequent phone correspondence. Close vision and focus capabilities to view computer screen, Company documents, and correspondence. Ability to lift up to 50 pounds repetitively. Work Environment | The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. There are no specific conditions affecting performance of this job. The noise level would be considered moderate for a business office with computers, printers, copiers, and light traffic. The position will often require more than forty hours of work per week. Individuals in this position may be exposed to radiation; however, radiation safety training and monitoring is required. • Shift work including but not limited to weekend call shifts Additional Information | Clean driving record and ability to travel to accounts and trade shows as necessary. Strong management skills required. Strong interpersonal skills for interacting with Physicians, customers, vendors and personnel required. Ability to problem-solve and handle customer service issues.
Description :
Pharmaceutic Labs is a start up within the compounding and admixing specialty pharmaceutical market. We are seeking dynamic individuals who want to apply their experience and knowledge to the growth and development of the company. The facility Manager will provide leadership, direction, and oversight to all functional managers, ( Quality Assurance, Production, Quality Control, Pharmacy, Distribution, and Administration) at the site level by performing the following essential duties and responsibilities below. This individual is also responsible for all budgetary items in regards to profit/loss of his/her individual site and ensure that all commercial and validation products are produced at the highest quality. Essential Duties and Responsibilities | •Manage all personnel, departments, and activities at his/her respective site. •Ensure that the facility maintains the highest GMP program •Work with the site QAO for all regulatory matters. •Monitor inventory and scheduling of all departments. •Institute policies and procedures that have been developed by upper Management and ensure compliance. •Work closely with all department managers on personnel needs and problems. •Analyze and make decisions effectively with changing business conditions. •Interact and negotiate will all levels of customers, principals and suppliers, as needed. •Anticipate future needs and opportunities and integrate them into the annual business plan. •Provide motivation and support to all personnel. •Communicate information regarding events, policy changes, benefit enrolments, etc. to all personnel. •Communicate vision, mission and objectives to all site employees. •Provide or ensure proper training for new employees. •Ensure maintenance and cleanliness is upheld at his/her site •Provide problem resolution to facilitate faster improvements and improved working conditions. •Budgetary responsibility. Responsible for profit/loss and the site’s overall bottom line performance. •Establish the appropriate KPIs for the business. •Provide senior management with monthly action plans after reviewing P&L statements. •Provide extensive customer service to both internal and external customers. •Oversee and analyze site performance including equipment productivity, personnel productivity, and raw materials consumption numbers. •Work on programs and systems to help reduce occupational hazards. •Responsible for providing data that will help achieve and maintain operational reliability and efficiency levels •Various other duties and functions relevant to the position •All other duties as assigned Breakdown of facility Manager Duties (including but not limited to) Daily: •Confer with all facility personnel to ensure daily productivity is met. •Assist as necessary to insure daily deliveries •Assess lab cleanliness and assign duties as required for maintenance. •Check with department heads to determine problems & needs. •Check with all departments to ascertain operational status. Confirm daily PM checks are performed. •Confirm drug inventory, consumable inventory, and utilization. •Confirm that daily compliance procedures are completed. •Confirm daily dose drawing log is complete •Insure that next day set-ups are performed. •Check end-of-day summary, note & rectify discrepancies, sign and file. •Monitor and address personnel issues as required. •Ensure daily reports are entered Weekly: •Ensure weekly inventory checks are performed and accurate •Reconcile Petty Cash and replenish if necessary. •Confirm that weekly compliance items are completed. •Audit & Confirm capital/parts inventory-ensure departments managers are performing this task •Check that delivery cases are road-ready. •See that weekly lab maintenance is performed (i.e.: mopping, waxing, bathrooms). •Confirm that waste is removed as needed. •Correct & Confirm Billing report for corporate submittal. •Submit weekly update. •Confer with Sales rep to determine operational needs and discuss any issues. oNew Accounts oProblematic accounts •Post vacation requests as required. •Assess personnel levels and make staffing adjustments via hiring as approved. •Conduct orientation for new employees (NH packet, handbook, radiation safety, etc.) Monthly: •Confirm personnel schedule. Maintains schedules on a rolling 3-month basis. •Confirm and submit inventory to corporate. •Perform monthly QA compliance audit. •Perform monthly CAPA review •Review and confirm outside vendor utilization oLab coat accounts oWaste removal accounts oLawn maintenance accounts •Review Petty Cash utilization •Confer with Sales Rep to discuss operational their support requirements. •Assist Sales with customer visits, conferences, etc., as needed. •Hold monthly facility meetings with staff for operational review and update. •Report on ongoing capital improvement projects and their status. •Review Budgetary items (you are accountable for your site’s profit/loss!) Quarterly: •Ensure that external audit is performed. Review and respond to external audit. •Assess compliance with budgetary requirements. •Provide feedback on anticipated budgetary needs to maintain current operational demands and meet future demands. oAssess ability to meet new product needs oOrder and install items as needed to meet future product needs. Semi-Annually: •Attend facility Manager meeting as required. •Project requirements for remainder of year and work with logistics, sales and other departments as needed to meet needs. •Assess physical plant and request items as needed for improvement of workflow, packaging and handling, and to meet future growth needs. Supervisory Responsibilities | This position requires extensive supervisory responsibilities. Personnel that report to the facility Manager may include: Pharmacists, chemists, QAO, Lab Assistants and technicians , Shipping Supervisors, Production Managers, Quality Control Specialists/Managers/Technicians, and Administrative Assistants.

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