This position reports to the Site Quality Lead. The QC Label and Batch Report Control Specialist will have overall responsibility to manage and control the creating, printing, and issuing of the sites labels and batch reports. This team member will be responsible for working with Manufacturing to prepare all necessary Batch Reports and Labels needed for production purposes. This position will manage the label cage and the inventory reconciliation of all finished SKU labels. In addition to daily Quality and Manufacturing needs, this team member will have weekly project work updating batch report and label templates. In addition, the team member will have daily responsibilities working in the QC lab to support with efficient sample turnover.
The role will be responsible for being a Quality representative in the manufacturing spaces and verifying adherence to CGMPs, Quality and Manufacturing SOP’s and procedures.
Key responsibilities of this position include:
- Manage and control the day-to-day operations which include creating, printing and issuing of the sites labels and batch reports.
- Oversee label inventory and issuing for daily production needs. Review all received Labels following Site SOP’s and protocols.
- Coordinate with manufacturing scheduling with manufacturing to meet the needs of GMS.
- Determine whether labels conform with established specifications. Monthly inventory cycles for all controlled labels.
- Provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations.
- Supply manufacturing and packaging operations Quality oversight – supplying the WHY as well as the HOW Quality is applied.
- Feedback to manufacturing on batch report completeness and cGMPs. Edit and update batch reports.
- Assure that all activities related to manufacturing and packaging processes comply with cGMP, applicable regulations and Zoetis Global Systems and Standards.
- Conducts inhouse QC testing including FTIR, aW, Moisture, Density, Microbiological plating and others.
- Participate in inspection readiness and preparation activities, including frontline and backroom support during regulatory site inspections.
- Assist the Quality Leadership Team, as a backup auditee for the Quality Control Laboratory, with preparation, and follow up of CAPA for internal audits and Health Authority inspections, as needed Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology. Understand and support business needs, provide quality guidance and facilitate resolution of quality issues in a timely manner.
As food safety is of the highest priority at Buellton, team members are expected to maintain all food safety policies and procedures including:
- Wearing clean uniforms, hairnets and beard covers.
- Frequent hand washing and sanitizing.
- Clean neoprene gloves.
- Reporting illness to supervisor or group leader.
- Clean and sanitize tools and equipment.
- Storing tools and materials in their designated place.
- Exceptional organization and housekeeping practices.
- Vigilant food allergen practices and procedures to prevent cross contact contamination.
- Reporting any food safety concerns to prevent potential contamination and food safety hazards.
- Diligently monitoring critical control points in accordance with our food safety plans.
- Supports with FSMA Documentation Supports Food Defense Plan Monitors or performs audits of Production department’s conformance with sanitation specifications, SOP’s and good manufacturing practices.
EDUCATION AND EXPERIENCE:
- Required High School diploma or equivalent with 5 years of relevant experience
- Preferred Bachelor of Science in Food Science, Food Technology, Biological sciences, Chemistry or other related sciences
- Demonstrated knowledge of label compliance, quality and scientific principles in a Life Science environment is desired.
TECHNICAL SKILL REQUIREMENTS:
- Good mathematical, science and computer skills preferred.
- Fluency in quality systems and regulatory compliance.
- Driven / Passionate about Quality performance and delivering results.
- Must have strong communication skills to nurture our food safety culture.
- Must be well-organized, detail oriented, and able to work within deadlines as well as under pressure.
- Strong written and oral communication skills
- Confident decision maker, self-accountability with an ability to develop and adhere to self-directed standard work.
- Drives for Superior Results
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with Quality and Business objectives
- Fluent in English (written and spoken).
- Business Fluency and awareness and Ability to be a Trusted Partner.
PHYSICAL POSITION REQUIREMENTS:
- Must be able to walk or stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Frequent lifting and carrying of 5 to 25 lbs.
- Regular reaching, bending, stooping, and twisting
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in [California] Base pay may vary based on location and other factors.
Base Pay Range: $26.40 - $40.50
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
