Quality Lead I - 1st & 2nd Shift
McComb, OH, United States1w ago
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Key details
- Location
- McComb, OH, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Full-time
- Experience
- 3–5 yrs
- Function
- Operations & Strategy
- Focus area
- other
- Visa sponsorship
- No visa sponsorship
- Posted
- 1w ago
Skills
data entryenvironmental regulationsgmphaccpincident reportinginternal auditmicrosoft officequality assurancerecord keepingsap
About the role
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.
Benefits in just 30 days! Your health and well-being is important to us at Maker's Pride. Full-time employees can access medical, dental, and vision benefits after just 30 days of employment. Plus, our comprehensive benefits package includes a 401(k), wellness benefits, and other programs, subject to applicable eligibility requirements.
This information is provided per the relevant state and local pay transparency laws for the location in which this position will be performed. Base pay information is based on market location.
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.
Benefits in just 30 days! Your health and well-being is important to us at Maker's Pride. Full-time employees can access medical, dental, and vision benefits after just 30 days of employment. Plus, our comprehensive benefits package includes a 401(k), wellness benefits, and other programs, subject to applicable eligibility requirements.
This information is provided per the relevant state and local pay transparency laws for the location in which this position will be performed. Base pay information is based on market location.