Plastics Qc Supervisor 1St Shift Jobs

Working knowledge of shop mathematics, and CATIA or blueprint reading and interpretation.

Perform conformity/first article inspections to ensure compliance with FAA approved procedures.

Ensure the proper use and storage of area tools and equipment.

Provide technical support to manufacturing personnel. .

Perform area inspections to ensure compliance with applicable standards and specifications. .

Participate in continuous improvement activities. .

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!

Perform method qualification/optimization of methods as per appropriate protocols.

Knowledge of LabWare LIMS and/or other QC data systems.

Detail-oriented with expertise in problem solving and solid decision making abilities.

Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel

Strong written and verbal communication skills are essential

Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, endotoxin and mycoplasma.

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.

Interpret data and make recommendations and reach decisions based on data and management input.

Determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.

Review and approval of environmental monitoring data and approval of data in Laboratory Information Management System for lot release.

Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, technical knowledge of aseptic processing and sanitization

Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Excellent effective written and verbal communication and interpersonal skills

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.

Experience with analytical chemistry, instrumental analysis, data compilation and knowledge of cGMP required.

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

Minimum of one year experience in a quality control analytical laboratory required.

Organizational skills, decision-making skills, and communication skills required.

Knowledge of USP and FDA regulations.

All employees are eligible to participate in our company-wide bonus program

May require Associate Degree or higher education/specialized training/certification, or equivalent combination of education and experience

Delegates effectively and exercises judgment when escalating issues to QC upper Management

Ensures quality management system procedures were accurate and current.

Knowledge and skill using basic computer software and hardware applications, including Microsoft Word and Excel

Reviews data for compliance to specifications and reports anomalous results to the Quality Manager and Quality Assurance, as appropriate

Provides expertise in translating regulatory requirements into practical, workable plans.

Key Capabilities, Knowledge, and Skills:

People management or leadership experience is required.

Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.

Be responsible to manage direct reports on day-to-day basis, including mid-year and year-end performances assessments.

Be responsible to create and manage development plans for direct reports.

Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations s,corrections and/or CAPAs.

Supervise a team of front line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team’s development goals

5+ years of experience in a GxP regulated laboratory environment

Demonstrated supervisory and leadership skills

2+ years of experience supervising a team

2+ years of experience with bioassay and SPR analysis

Experience with cell culture, aseptic techniques and automated liquid handling robots (ie. Hamilton)

Manages the calibration database for the facility

Manages and coordinates external calibration of electronic equipment in a timely manner

Experience with SPC, Quality Improvement Programs and ISO fundamentals preferred

Plans and performs calibration of plant measurement equipment within company required specifications; makes operating adjustments as required

Support Research and purchase gauging as requested to support new product/process development

Obtains quotes for needed equipment repairs, replacement gaging

Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements

Strong oral and written communication skills

Office Suite experience (Excel, Word, Access, and PowerPoint)Bachelor of Science in a scientific area of study

5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company

Experience working in a cGMP laboratory required

Experience working in a CMO (contact manufacturing/development organization) preferred

BS in Chemistry or in a science-related field or equivalent. Five to seven years pharmaceutical experience preferred.

Experience with the following analytical techniques is required:

Additional experience with the following analytical techniques are highly desired:

Must possess excellent written and verbal communication skills.

For APIs: Arsenics, UV, HPLC, GC

For Pharmaceutical products: HPLC, GC

ESSENTIAL FUNCTIONS, RESPONSIBILITIES, OR JOB DUTIES:

College degree and/or 2-5 years related experience and/or training.

Five (5) years experience as a Group Leader and/or supervisory position in Warehousing.

Schedule labeling to make sure orders are ready by ship date;

Schedule employee hours and vacations;

Follow Seneca's Warehouse Systems Manual and Quality Manual;