MQ Lead I - Weekend E Shift

Job Description

Job Description

Description:

Job Summary:

With your approachable personality and knowledge of our MQ processes, you will perform investigations on customer complaints, non-conformances, and deviations; perform inspection functions; audit packaging and manufacturing lines for GMP and SOP compliance; and coordinate training efforts for employees. You will work with operations and manufacturing support personnel to address quality control issues and make recommendations for immediate corrective action when necessary to ensure optimum product quality. You will work closely with MQ Supervisors to assist with continuous improvement initiatives, safety, and operational goal setting to help us succeed.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Coordinates all inspection activities on the respective shift, including dispositioning of materials. Performs inspections. Ensures the availability of adequate materials and supplies necessary to conduct sampling and inspections. Delegates daily task assignments for the MQ Inspection team.
• Conducts and documents investigations as necessary. Closes Nonconformance Investigations. Provides MQ Inspectors with investigation assistance.
• Assists with customer complaint investigations.
• Conducts internal audits for cGMP compliance.
• Tracks completion of deviations and holds and ensures timely completion of each.
• Performs RCA on manufacturing nonconformances. Provides long term preventative action measures for manufacturing nonconformances.
• Assists Packaging and Processing departments with troubleshooting and resolving daily issues. Coordinates the implementation of rework with Production personnel and tracks the status of lots that are on hold status.
• Assists management with monthly metrics that are tracked for the department.
• Identifies and immediately notifies management about actual or potential food safety issues, including resolving food safety issues within scope of work.
• Engages in training (i.e. cGMP, on-the-job training) and development of MQ employees by mentoring and following up with team members on a regular basis (including new employees), reinforcing company policies, culture, and expectations, ensuring they feel supported, are receiving proper guidance, training, resources and are adapting to the company’s culture and team. Works with supervisor to include any gaps into their training plan and ensures all employees are current on required training.
• Reviews and updates departmental standard operating procedure to ensure cGMP compliance.
• Closes nonconformance investigations within established timelines.
• Completes necessary documentation, including LIMS and Oracle entries. Reviews documentation for completeness and compliance with GMPs and SOPs. Releases materials for use and reviews documentation for completeness. Participates in Tier II meetings in absence of supervisor and MQ Lead II.
• Assists with Continuous Improvement efforts within the MQ department that enhance safety, quality, production methods, equipment performance, and efficiency.
• Assists in the skills development of MQ Inspectors and Samplers.
• Complies with safety and GMP requirements.

SAFETY RESPONSIBILITY STATEMENT

Supports a culture of safe production and exhibits safe work practices. Actively participates in the safety program by engaging in safety activities. Effectively provides and accepts constructive peer-to-peer feedback on safety performance. Adheres to policies, procedures, SOP’s, safe work practices, and safety policies and procedures. Reports ALL workplace incidents to supervisor immediately. Communicates concerns to supervisor, reports hazards, and provides input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates on safety teams and/or completes safety-related activities as part of regular job responsibilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• High school diploma or equivalent and minimum of five years quality related experience OR equivalent combination of experience and education.
• Additional post-secondary education in a science field and prior team leadership experience strongly preferred.
• Experience in quality processes, inspection, and GMP environment required.
• Previous dietary supplement industry experience strongly preferred.

PERFORMANCE ABILITY

Comprehensive knowledge of all work centers within the area of responsibility and ability to work in any area of MQ Inspection in which he/she has been trained based on the needs of the department. Strong technical writing skills required, including writing quality sections of quality nonconformances. Food safety and regulatory knowledge. Excellent problem-solving skills and ability to apply critical thinking skills to a variety of manufacturing issues and make solid decisions to solve them, including ability to investigate issues and make decisions on immediate corrective actions and to independently close investigations by determining and documenting root cause and effective corrective actions. Excellent communication and listening skills for engaging with a diverse team, along with strong teambuilding abilities to motivate, and lead staff. Effective time management skills to prioritize and handle multiple tasks in a fast-paced environment with urgency and flexibility. Leads by example, embodying the company’s core values and tenets, and ensuring adherence to company policies, procedures and safety regulations. Good leadership, training and coaching skills needed to develop and mentor team members, train on current and new procedures, and utilize KPIs for data-driven decision-making while implementing continuous improvement initiatives. Ability to collaborate effectively with Production. Ensures approach and interactions with employees and cross-functional teams are personable and welcoming. Consistently diffuses conflict with compassion and model’s our culture, core values and tenets. Demonstrates responsible, ethical and honest conduct. Maintains strict confidentiality of information.

LANGUAGE SKILLS

Ability to read and interpret documents such as product specifications, departmental instructions, and procedure manuals. Ability to write e-mails to communicate within MQ and with operations personnel. Accurately and truthfully completes documentation. Excellent verbal communication and actively listening skills. Bi-lingual verbal communication skills helpful.

MATHEMATICAL SKILLS

Ability to apply concepts such as fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.

REASONING ABILITY

Ability to compare results to specifications to determine if result meets requirements. Ability to interpret a variety of instructions. Excellent problem-solving and critical thinking skills required. Ability to investigate situations and reasons to determine root cause.

OTHER SKILLS AND ABILITIES

• Ability to work a flexible schedule, including off shifts and weekends, and to travel to other facilities.
• Excellent computer skills with Word and Excel required.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear; stand and/or walk throughout the facility; ascend and/or descend stairs; forward bend and squat; use hands to inspect, handle, and feel; and reach with hands and arms. The employee is regularly required to enter information into a computer, handle product in various stages and forms (i.e. raw materials, work in progress, and finished products in liquid, powdered, and tablet forms), in addition to equipment and/or tools. The employee frequently is required to use his/her sense of smell. Accurate color perception to inspect products and assess visual quality.

The employee must regularly lift, move (in some cases drag items), slide, raise and/or place:

• Lift 5lbs. from ground to 61 inch height and return.
• Push with 30 lb. force for up to 25 feet and then pull to start.
• Lift 35 lbs. from 5 inches off ground to 48 inches overhead and return.
• Lift 50 lbs. from waist high and carry for 5 feet and back.
• Lift pallet from floor onto its side and move 10 ft. and back.