This position will plan and conduct activities concerned with prevention and correction of product and process deficiencies to achieve high outgoing quality levels, Including, but not limited to, product safety inspections and audits, sampling inspections, product trials, process validation, material testing, train others in quality work instructions and procedures and fill in for QC Techs as needed. Actively participate in CI activities to eliminate process and operational waste. Oversees and supports the application and maintenance of quality standards for all manufacturing, testing and production processes.
Assists the Quality Assurance Manager in developing, maintaining procedures and work instructions, and establishing programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment.
ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:
Assist in the analysis of quantitative and qualitative data.
Assist product safety inspections, GMP's, and IMS internal audits as required. Keep records and logs as appropriate.
Assist and train on incoming inspection and testing for incoming material received from various suppliers. Identify status of material and properly approve/reject material.
Work with QC Techs on first articles approvals, documentation, and sample retention (retains).
Work and assist in the troubleshooting of the SPC system.
Issue CoA or CoC per Customer requirements.
Perform QC Tech tasks as required or in absence of QC Tech. including covering shifts as required.
Participate in and take on projects resulting in process streamlining, improvements and cost savings.
Work with teams to identify problems, analyze information to develop and implement process solutions.
Other tasks, projects, and assignments as needed.
Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality procedures.
Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits.
Collaborates in the investigation of customer complaints; with departments managers and supervisors to develop improved processes.
Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, re-work, corrective actions, and re-validations.
Plans and implements goals and objectives as established for the department.
Directs and organizes work priorities for quality technicians.
Assis tin resolving team's challenges to achieve daily goals.
Establishes and maintains safety operations by adhering to procedures and policies
Performs other related duties as required
REQUIREMENTS:
Collaborative teamwork
Knowledge of Statistics, SPC and ISO9001
Computer literate with proficiency in MS Office.
Detail and multitask oriented with good communication skills.
Must have ability to train and coach personnel.
Work well under pressure and in a fast-paced environment.
Motivated and self-directed team player with ability to work with minimum supervision and good interpersonal skills.
Excellent facilitation and coaching skills.
Adaptability to work demand shifts/Flexibility.
SUPERVISORY RESPONSIBILITIES:
Oversees QC lab technicians.
EDUCATION/EXPERIENCE:
Bachelor's degree in chemistry, biochemistry, or related field and 1 year of supervisor experience in manufacturing environment is preferred, / or High school diploma with 3 years of quality supervisor experience in manufacturing environment.
2 years of hands-on experience in the lab,
GMP's Quality auditing skills preferred.
Knowledge of ISO 9001, GMP or equivalent experience.
Knowledge of MS Office and ERP systems
Lean or 6 Sigma certification is a plus
ASQ-CQE certification is a plus.
Bilingual English/Spanish is a plus
LANGUAGE SKILLS:
Ability to communicate and present reports.
Excellent communication proficiency with oral and written skills
Ability to read, analyze, and interpret general business periodicals, technical procedures, or governmental regulations.
Ability to write reports, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers.
MATHEMATICAL SKILLS:
Strong math skills, including algebra and statistics.
Complex problem-solving skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
REASONING ABILITY:
Solid independent decision-making abilities
Ethical conduct
Excellent collaboration skills
Solid Independent decision-making abilities
Ability to solve critical problems when performing a wide variety of duties
Independent decision-making abilities and judgment to work independently toward general results, devising new methods or concepts, modifying or adapting standard procedures to meet new conditions.
PHYSICAL DEMANDS:
While performing the duties of this job, the employee may be required to talk and listen. This position is mostly sedentary and requires little repetitive hand movements, may require some standing, walking, bending and lifting throughout the workday. Specific vision abilities required by this job include close vision and the ability to work in front of a computer monitor for extended periods of the day.
WORK ENVIRONMENT:
Professional office environment. Our manufacturing plant is not environmentally controlled. Changes in humidity and temperature occur throughout the year. Although machine noise is constant, conditions are maintained within standards that meet OSHA mandated requirements, and which our Safety Committee monitors.