OverviewJob Summary:ABM Life Sciences is seeking a highly motivated QA Supervisor to support our client, Lonza , in maintaining compliance with GMP regulations and ensuring the highest quality standards in facility operations. The ideal candidate will have experience in deviations, CAPA, investigations, and facilities management , particularly in pest control . Additionally, this role will be responsible for verifying training records for GMP cleaning team members and ensuring compliance with Good Documentation Practices (GDP).Pay: $75k-85KThe pay listed is the salary range for this position. Any specific offer will vary based on the successful applicant’s education, experience, skills, abilities, geographic location, and alignment with market data.Benefit Information: ABM offers a comprehensive benefits package. For information about ABM’s benefits, visit ABM Employee Benefits | Staff & Management (https://wpe-media.abm.com/wp-content/uploads/2025/ABM2025EmployeeBenefitsStaff&ManagementNo%20Date%209.5.24.pdf)Key responsibilities:
Performance and coordination of environmental monitoring.
Work hours may vary dependent on the demands of individual manufacture events.
Prepare/ establish standard operating procedures, write and coordinate excursion reports and environmental investigations, and write/ review trend reports.
Ensure corporate, cGMP, and regulatory guidance of all activities within the department. Perform review of data collection and assay documents.
Represent QC, as needed, in audits and associated client exchanges. Provide communication and coordinate schedules/ efforts with other departments to support manufacture operations.
Leads, mentors, and coaches staff through routine one-on-one meetings, team meetings, and effective performance management. Sets and delivers on individual and team goals that support the group and site strategy.
Monitor and approve timesheets and other administrative duties for personnel
Essential Functions:
Lead and oversee QA/QC activities to ensure compliance with GMP and regulatory requirements.
Manage and coordinate deviation investigations , CAPAs , and root cause analysis to drive continuous improvement.
Conduct and oversee investigations related to facility issues, including pest control , to ensure regulatory compliance and product integrity.
Lead, verify and approve training records for GMP cleaning team members, ensuring that all personnel are properly trained and qualified.
Ensure adherence to Good Documentation Practices (GDP) and oversee document control processes, including logbooks.
Collaborate with cross-functional teams to drive quality improvements in facility operations and cleaning procedures.
Conduct routine facility inspections and audits , providing recommendations for corrective and preventive actions.
Develop and maintain SOPs related to quality and compliance activities.
Serve as a key QA contact for regulatory and client audits, ensuring all required documentation is available and accurate.
Minimum Qualifications & Requirements:
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Microbiology) or equivalent experience.
3-5 years of experience in GMP-regulated environments , preferably in QA/QC roles .
Strong knowledge of deviation management, CAPA systems, and investigations within a GMP setting.
Experience with facility quality oversight , including pest control programs .
Ability to verify and assess training records for GMP cleaning personnel.
Strong understanding of Good Documentation Practices (GDP) and regulatory expectations.
Excellent communication skills, both verbal and written.
Experience in conducting internal audits and working with cross-functional teams.
Detail-oriented with a strong ability to identify compliance risks and implement corrective measures.
Preferred Experience and Knowledge:
Experience in biopharmaceutical or contract manufacturing environments.
Knowledge of environmental monitoring programs and sanitation control measures .
Familiarity with FDA, EMA, and other regulatory agency requirements .
Ability to work in a fast-paced environment and manage multiple priorities effectively.
Preferred Qualifications:
Bachelors degree in scientific discipline, Microbiology preferred.
Advanced years of experience in Quality Control.
Adherence to cGMPs is required at all times during the manufacture of APIs
Level 3 gowning qualification is required.
Demonstrated knowledge in and microbiological assays, microorganism identification techniques, environmental monitoring, associated regulator guidelines, and aseptic processing. Should possess knowledge of how to execute team methods/procedures and operate equipment. May need to support and/or execute analyst tasks on a non-routine basis.
Develops training plans and performs identification and remediation of training gaps.
Proficient in the use of spreadsheets, databases, and word processing software.
Knowledge of SAP, MODA, and TrackWise systems a plus.
Uses experience and knowledge to solve problems, make decisions or make plans for their area. Makes recommendations for department. Erroneous decisions or failure to achieve results may cause delays in schedules.
Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work.
Demonstrated experience in management of complex tasks and projects
Able to plan activities for self, team, and group projects on an on-going basis. Works with manager to ensure group timelines are aligned with department goals.
Prioritizes work of team based on input from management and is able to clearly communicates rationale for priorities.
Can clearly and confidently communicate expectations effectively to all members of their team.
Uses mediation skills to avoid or resolve conflict. Is able to deliver criticism in a constructive manner.
In conjunction with program management team, helps develop loyalty and trust with customers. Able to make and deliver on promises of projects within group control.
REQNUMBER: 111461All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.