Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: + engage in work that matters to our customers and the patients they serve + learn new skills and enjoy new experiences in an engaging and safe environment + strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more! Can we make this broader language, so it fits in all markets, e.g., that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Clean Room Environmental Monitoring Supervisor is responsible for the daily operations of the Cleanroom Services analysts based in Marlborough, MA. This role may be classified as a Supervisor or Associate Manager depending on leadership experience. This role provides technical leadership for the team in a CDMO environment. In this role, you will be responsible for the supervision of hourly employees in order to meet the safety, environmental, compliance, quality, productivity, as well as to meet customer delivery dates. As the Location Leader, you will provide direction and leadership for your assigned team in the areas of safety, quality, productivity and engagement to ensure goals are met. This position is also responsible for overseeing employee training, enforcing all rules, policies and procedures, recommending and applying disciplinary action when required, verifying work hours in timecards. This role ensures that all CRS activities are in compliance with company SOPs, GMP/GLP standards and FDA/EU and ISO 17025 regulations. Analyzes information for accuracy and compliance to internal procedure, CGMP and other regulatory guidelines. Responsibilities + Oversee the day-to-day operations of the Cleanroom Services Department. + Collaborate with CRS leadership team to create daily schedules + Lead team huddles to ensure effective communication, planning and resource use + Regularly inspect work to ensure consistency in the quality and pace of work + Ensure all work is completed in a timely manner by trained team members following written procedures in a cGMP compliant environment. + Delegate projects and follow up to ensure effective delegation, with objectives met on time and within budget + Ensure that the Cleanroom Services Department is maintained in an audit ready state: Perform audit for accuracy and completeness, oversight of training, audit technical documents (e.g. reports, protocols, test procedures, SOPs, etc.), oversight of compendial method verifications and method transfers, and manage quality events. + Audit schedules to ensure that training, BMRAM, Master Control, Quality Event and other tasks are included + Use checklists and system reports to ensure compliance + Represent Cleanroom Services Department interests in meetings, collaborate and cooperate to achieve cross-functional improvements and business goals + Support cross-training, resource sharing and diverse career paths + Create departmental systems, departmental monitors, and foster a culture of continuous improvement focused on value to the customer + Improve the consistency and predictability of quality, pace and cost of the Cleanroom Services Department. Create flowcharts and optimize the sequence of processes and systems. Eliminate waste and create flow. + Assist with creation of budgets, forecasts, plans, models, and business cases to support projects to improve quality, pace, profitability, and growth. Review and approve expenditures within allocated budgets. + Assist with selecting team members. Partner with HR to: + Recruit, develop and promote talent, providing regular feedback for team members. + Discipline and terminate team members that do not meet expectations. Qualifications/Skills + Communicate clearly and effectively both orally and in writing with clients and other employees. + Influential leadership to motivate team members + Goal-oriented, with ability to prioritize and manage multiple tasks and numerous projects in a fast-paced environment. + Strong problem-solving abilities. + Ability to review, compile, and analyze information to prepare reports. + Proven ability to lead teams. + Demonstrate the capability for continued growth and technical contributions. + Excellent analytical and problem-solving skills, with the ability to think strategically. + Ability to write reports and business correspondences. + Ability to listen and respond well to external customers, partners, and colleagues at all levels. + Highly effective team and interpersonal skills with the ability to work across numerous management disciplines. + Highly goal and result oriented. + Ability to discuss and reach an agreement in a professional manner. + Ability to manage and analyze a situation and develop a professional solution to the organization Education, Experience & Licensing Requirements + High school diploma or Associate’s degree required. + Bachelor’s degree in Chemistry or Microbiology or other Life Sciences degree preferred. + 3+ years of experience in a regulated industry with at least one year of related experience leading / managing employees, preferred. At the Associate Manager level at least 2+ years leadership experience is required. + Experience supporting medical device and pharmaceutical manufacturing. + Experience performing root cause analysis Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. #LI-SK1 Travel: This role frequently performs work at client sites, so travel to and from client sites is part of the typical workday. Company vans are provided for travel to client sites, most of which are in southern New England. Approximately 10% of assignments are multi-day requiring overnight accommodation. 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. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Environment and Protective Equipment: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. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.