Quality Lead I - 1st & 2nd Shift

Maker’s Pride, LLC; McComb (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Flex spending accounts

Short & long-term disability

Paid holidays and vacation

Bonuses opportunities (referral, etc.)

Job summary

Maker’s Pride, LLC in Ohio is seeking a Quality Lead to serve as the QA shift contact, manage FSQA programs, and back up document review tasks within a collaborative QA team.

You will ensure compliance with GMP, FSMA, HACCP and SQF expectations, oversee audits, CAPAs, and supplier lab activities while coordinating with production and other departments to meet customer and regulatory requirements.

Qualifications

• Experience in FDA/USDA QA environments preferred.
• Knowledge of GMP, HACCP, FSMA PCQI beneficial.
• Willingness to work overtime and weekends as needed.

Responsibilities

• Monitor QA Technicians during in-process checks.
• Participate in Internal Audit program.
• Perform GMP Audits and oversee incident reports.
• Lead RCA-CAPAs and support mock traces/ recalls.
• Oversee PEM and Non-PEM swabbing programs.

Skills

Communication skills

Attention to detail

Problem solving

Autonomy

Team collaboration

English proficiency

Education

High school diploma or GED

Associate degree in science

Tools

MS Office Suite

SAP

Job description

What We Offer

We offer a competitive wage and wide array of benefits including:

• health/dental/vision insurance
• flex spending accounts
• short & long-term disability
• paid holidays and vacation

What We Offer

We offer a competitive wage and wide array of benefits including:

• health/dental/vision insurance
• flex spending accounts
• short & long-term disability
• paid holidays and vacation
• bonuses opportunities (referral, production, etc.).

Job Summary

The Quality Lead is responsible for serving as a point of contact for QA Technicians on the shift when other supervision is not available, manage assigned FSQA programs, serve as backup for document specialist reviewer tasks, maintain data entry into associated computer systems as necessary, and work with the QA team and other department personnel to meet requirements, assignments, trials, and responsibilities

Hours Of Operation

Monday through Friday + Overtime/Weekends

1st Shift: 6:00AM to 2:00PM

2nd Shift: 2:00PM to 10:00PM

Job Duties

Duties may include, but are not limited to the following:

• Monitor and assist QA Technicians performing in-process QA checks
• Participate in the Internal Audit program
• Perform GMP Audits
• Oversee Incident Report generation and communication
• Lead and assist in managing RCA-CAPAs
• Participate in Mock Traces / Recalls as necessary
• Perform and/or oversee the PEM and Non-PEM swabbing programs
• Assist in consumer/customer complaint investigations
• Serve as main QA contact for trials or new product qualification activities as assigned
• Track and order lab supplies
• Monitor rework processes when conducted for compliance to standards
• File paperwork related to the GFSI system
• Maintain hold inventory records
• Participate in sensory and other product reviews as required
• Provide necessary data for KPIs
• Perform QA Technician duties when required as back up
• Follow Good Manufacturing Practices (GMPs) at all times
• Comply with all safety, health and environmental regulations as prescribed bylaw
• Comply with all Company rules, regulations and policies
• May be required to work weekends from time to time
• Perform other duties as assigned by QA leadership

Required Competencies & Knowledge

Knowledge of

• GFSI and FSMA requirements
• Environmental Monitoring Programs
• QA Technician role and responsibilities
• Customer specs and expectations
• Exhibited experience with necessary SAP transactions

Skill In

• Must have excellent oral and written communication skills
• Strong self-confidence
• Excellent problem-solving skills and the ability to work with autonomy
• Must be accurate, detail-oriented and maintain the utmost confidentiality

Ability To

• Communicate in English to give and acknowledge instructions/problems
• Physical and mental ability to work in excess of 40 hours per week
• Add, subtract, multiply and divide in various units of measure, using whole numbers, common fractions and decimals
• Define problems, collect data, establish facts and draw valid conclusions.
• Write routine reports and correspondence
• Interpret a variety of instructions furnished in written, oral, diagram and/or schedule form
• Work well with others in stressful situations and meet deadlines as necessary
• Handle multiple priorities and tasks
• Excellent keyboarding, record keeping and follow-up skills
• Proficiency in: MS Office Suite and SAP

Work Environment

• Maintain harmonious working relations with employees from all departments.
• Maintain harmonious working relations with management from all levels.
• Communicate effectively with all employees and management.

Physical Requirements

• Reaching with hands/arms throughout the day.
• Ability to use hands and fingers.
• Ability to see, hear and talk.
• Ability to work in light to moderate noise levels.
• May be required to walk up to 400 yards to work and break areas.
• May climb steps to and from work and break areas.
• May have to work in hot or cold conditions depending on type of production operation

Minimum Qualifications

• High school diploma or GED equivalent (QAD approval otherwise)
• Associates Degree in science field preferred, but not required
• Three – Five years of QA experience in FDA/USDA facilities
• Experience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP), FSMA (PCQI), and SQF all pluses

Sponsorship for work authorization is not available for this position. It is the candidate’s responsibility to ensure they are legally authorized to work in the location to which they apply.

Maker's Pride is an Equal Opportunity Employer.