Qc Environmental Monitoring Supervisor Jobs

0-1 years of management experience

Bachelor’s degree in life sciences or equivalent preferred or relevant experience

2 years GMP experience or other regulated industry

Must be able to read and understand English-written job instructions and safety requirements.

Medical, dental and vision benefits effective on first day of employment.

Catalent offers rewarding opportunities to further your career!

Supervise operational activities of laboratory personnel in an organized and efficient manner to prevent any delays in microscopy testing.

Author/Review/Approve microscopy technical reports to support investigational conclusions and regulatory communications.

Author/Review/Approve protocols, deviations, and investigations.

Train personnel on department procedures and testing methods and protocols

Represent department in meetings with Production, QA/RA, Packaging, and other related departments.

Advise, recommend, and implement resolutions for quality issues and non-compliance.

Identify problems that may adversely affect test performance, takes authorized corrective action, and notifies management

Experience leading a team, good communication and organizational skills

Minimum 2 years’ experience working within a GMP/regulated environment, under a Quality System required

Maintain a team environment while simultaneously maintaining efficient lab operations and managing shift-to-shift communications

Identify ways to optimize testing processes, assay setup, layout, and job execution that improves lab workflow

Ensure all background preparation work, such as ordering, is done within a timely manner to prevent delays to the manufacturing schedule

Interacts with clients for assay qualifications and onboarding activities.

Experience leading/supervising a team is highly preferred.

Ability to manage timelines and meet internal/external deadlines.

Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals.

Strong communication skills (verbal and written).

Oversee and schedule staff of Quality Control analysts.

Have 2 years of technical experience plus 2 years of supervisory/management experience.

Lead the Quality Management (QM) pillar for the facility.

Assigning responsibilities for specific work or functional activities to QC laboratory technicians.

Directing laboratory experiments and production formulations and processing trials to meet the customer’s requirements as to cost and quality.

Have excellent customer service skills.

Demonstrate strong MS Excel working knowledge.

Interacts with clients for assay qualifications and onboarding activities.

Experience leading/supervising a team is highly preferred.

Ability to manage timelines and meet internal/external deadlines.

Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals.

Strong communication skills (verbal and written).

Oversee and schedule staff of Quality Control analysts.

Advanced knowledge/experience with regulatory requirements, policies, and guidelines

Prior leadership experience, microbiology project management accepted

Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing

Detailed knowledge and experience in applying statistical concepts to laboratory data

Ensure accuracy and completeness of performed analytical method qualification, validation, and transfer activities

Set priorities and manage work assignments

Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.

Schedules and monitors daily operation of department based on projected client demands.

Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.

Approval of investigations and documentation of non-confirming events and OOS.

Recommends process improvements to achieve greater efficiency within the department and between sites.

Participates in department and cross functional meetings.

Oracle, Reliance ETQ, 1factory ERP and Quality management systems experience preferred.

Informal management/ team lead experience.

Performs supervisory and administrative duties associated with inspection personnel management.

Minimum of 3 years applying quality management systems in their role

Managing First Article Inspections and ad hoc inspection requirements through Jira.

Identifies problems, and proposes resolutions that are timely, cost-effective, and meet quality requirements.

Bachelor’s Degree required and four (4) plus years of experience. Or an equivalent combination of education and experience.

Responsible for all Material Certification submittals for the Company and outside customers as requested.

Delegate responsibilities & expect accountability

Safely operate various types of equipment related to work requirements.

Strictly adhere to safety requirements, policies, and procedures as per company policy.

Must be willing to travel to each jobsite and work away from home when required.

Possess oral and written communication skills for communicating to employees, management, and other departments.

Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.

High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.

Possess interpersonal skills and demonstrated teaching/coaching experience.

Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technician(s).

4+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.