As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: North Billerica, Massachusetts
job type: Permanent
salary: $80,000 - 108,000 per year
work hours: 9 to 5
Supervise the QC Microbiology group to successfully meet requirements. Provide support and technical expertise. Drive laboratory quality, efficiencies, and improvements, and ensure cGMP compliance. QC representative on initiatives, projects, and committees.
Oversight of QC release and stability testing of finished product (microbial limits/bioburden, endotoxin, sterility, and BI testing); environmental and utilities monitoring and microorganism identifications and trending for hot and cold manufacturing operations; aseptic technique and cleanroom practices (e.g. gowning/disinfection); validation studies testing and related protocols/reports; project support. Multi-shift, 7 day a week operation including holidays.
Note: Analysts (& Lead if applicable) report directly to Supervisor.
- Supervise staff to successfully meet area specific requirements.
- Responsible for all aspects of the laboratory operation, e.g., training, schedule, lab supplies, equipment maintenance and calibrations, and safety. Ensure methods are current and validated/verified. Ensure that QC testing, recording, collection, and maintenance of data, are performed in accordance with SOPs, cGMPs, company standards, policies and regulatory requirements. Perform testing as needed. Verify and approve data.
- Supervise, organize, and coordinate the activities of analysts in a fast-paced operation, with high performance and accountability. Includes staffing, training, reviews, balancing workload, and working on continuous compliance, process, and efficiency improvements. Supervise individual and group performance to meet requirements, ensuring work is performed in a quality, compliant, and timely manner and meets business priorities/objectives. Flexibility to accommodate changes and priorities. Lead staff to achieve professional growth and attain established goals. Provide direction to team, act on issues, make decisions, and report on progress. Monitor and actively assist with daily operations as required to meet schedules or resolve problems. Work with Manager to utilize meetings effectively, facilitate/lead team VSM efforts, and use Lean/project management tools as appropriate.
- Administer and execute policies and procedures that impact staff.
- Lead analyst resource planning, participate in Budgeting/CapEx process, and ensure lab expenditures are aligned.
- Use and ensure timely staff use of quality management systems (QMS) such as training, investigations, deviations, CAPAs, SOP reviews/revisions, change controls, and execution of protocols. Take main or reviewer roles (e.g. lead investigator, SOP business owner, change control author, protocol study owner or reviewer). Resolve routine and non-routine problems independently by utilizing problem solving and technical skills, and partnering with appropriate resources.
- Utilize and ensure appropriate staff use of a wide range of electronic systems such as ERP, QMS, LIMS, and equipment software. May be administrator for area-specific software systems and on notifications for responding to alarms.
- Ensure audit readiness of area/processes. Interface with external regulatory inspectors and internal compliance auditors. Ensure timely completion of any commitments made.
- Represent QC on relevant initiatives, projects, committees, and/or update/planning meetings, providing area perspective and expertise. Accountable for meeting requirements.
- Leader who works well independently and in teams with quality and attention to detail. Strong communication skills both oral and written, professional conduct. Effectively and efficiently participate in tasks in a quality manner. Solid interpersonal skills, ability to lead and interact with a diverse group of individuals at various levels (mainly internal departments and vendors).
- Understanding of current relevant US guidelines (e.g. cGMP, FDA, USP). Full knowledge of industry practices for assigned area and of specialized functions. A comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to problems and situations ordinarily encountered. May serve as area expert, also utilize other experienced staff SMEs.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. Ensure a safe working environment.
- Actively demonstrate the values of accountability, quality, efficiency, customer service, collaboration, and safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
- Typically requires min. 5 years' experience with a BS in a related scientific/technical discipline or equivalent combination of education and relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous Lean and/or project experience preferred.
- Flexibility with scheduling requirements for staff and supervisor support of them may include evenings, weekends, and holiday coverage, including during adverse weather conditions. Some non-routine travel may be required.
- Supervisor and direct staff working with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and must be able to lift/move materials, e.g. 30 lb. portable equipment, 50 lb. lead/shields.
skills: Quality control, SOP, CAPA, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System, ERP System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.