MAIN DUTIES & RESPONSIBILITIES

• Perform annual reviews and merit increases with employees.
• Perform and record employee disciplinary actions as needed to correct performance issues.
• Resolve conflict and assure harassment free work environment is available to all employees.
• Interact regularly with employees to assure a good flow of communication.
• Interact with multiple departments to assure accurate communication regarding the status of quality issues.
• Insure appropriate communication between Capstone and its customers.
• Manage and resolve customer complaints through the internal CAPA quality system.
• Manage the quality systems as defined by Capstone procedures.
• Manage other quality departments as necessary, e.g. regulatory, documentation, etc.
• Under direction of the Director of Quality Services, perform on-going quality projects to assure quality and regulatory compliance.

• Make major quality decisions (when quality limits are less defined and more subjective).
• Inform Director of Quality Services of all critical quality issues (when quality limits are ill-defined and very subjective often requiring input from multiple departments for disposition) and assist in their resolution.
• Assist with enforcing food safety program and procedures, GMP policy, and personnel hygiene policies.
• Monitor that food safety procedures and documentation are being followed, problem solving as relates to food safety issues, and assisting with compliance of HACCP, GMP, and SQF.
• Take a lead role in external audits and customer interaction.
• Responsible to cover food safety job duties of key personnel in your department during their absence.

• Quality Manager backs up the Director of Quality Services when the Director of Quality Services is unavailable.
• QA Supervisor backs up the Quality Manager when the Quality Manager is unavailable.

• Ensure compliance to CFR 21 Part 111.0.
• Ensure Compliance with Australian GMP requirements, per Chapter 2, as related to raw, in-process materials and finished goods.
• Provide accurate reports and presentations which convey the status of the various quality systems.
• Other duties may be assigned as necessary by the Director of Quality Services.
• Accountable for the quality of work
• Accurate and timely recording of information on specified documents
• Proper use and care of equipment and materials issued to work area

REQUIREMENTS

• B.S. in the Sciences or related discipline, five (5) to seven (7) years related experience preferred or additional years of education and experience may be substituted for each other, as determined by Human Resources and the Director of Quality Services.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Ability to operate/use personal computer, office equipment, telephone, and various word processor and spreadsheet software.

• Ability to exchange information with others clearly and concisely; to present ideas, facts, and technical information.

• Ability to work with minimal direct supervision.

• Ability to work well with others in a team environment.
• Ability to effectively present information and respond to questions from QA Supervisor, other internal departments and Customers.

• Must be able to understand, speak, read and write in English in order to perform the essential functions of the job as they relate to comprehension of laws, regulations, standards, documents and other internal and external communications.
• Ability to keep proprietary information confidential is critical to this position.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Knowledge of both standard and metric systems.

WORK CONDITIONS

• Subject to normal office environment, but must occasionally enter production areas, which may include the following conditions:
  • High noise levels

  • Dust, fumes and odors
• Subject to various means of business travel (planes, trains, busses, automobiles)