SUMMARY OF POSITION:

The QA Technician is responsible for Quality Control/Assurance tasks and processes within Boiron facilities in accordance with Standard Operating Procedures. The candidate must be versatile, independent, and an effective communicator.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Quality Assurance and Quality Control duties in the following areas:

• Development of assembly/packaging project specifications and master batch records;
• Quality Control inspection of finished products packaged domestically;
• Quality Control inspection, documentation, release and organization of finished product specialties and generics received from Boiron France;
• Quality Control inspection and disposition of materials and product used in assembly projects;
• Compliance review of assembly project batch documentation and finished product release;
• QA Documentation retention, filing and maintenance;
• Support of product quality investigations as requested;
• Support regulatory inspections as requested;
• Inspect and process product returns;
• Review and communication of environmental monitoring data;
• Collaborate with Branch teams to harmonize compliance activities;
• Contribute to branch Standard Operating Procedures as requested as an SME;
• Maintain open communication, trouble shoot, and propose solutions with branch teams to promote the quality culture, resolve challenges and avoid conflict;
• Other duties as assigned.

REQUIREMENTS:

• Education in Life Science or related field or 1-2 years of experience in a Quality or Technical field preferred.
• Understanding of cGMP and pharmaceutical regulatory guidelines preferred.
• Knowledge of the JD Edwards inventory management system preferred.
• Knowledge of Microsoft Office software with ability to use and willingness to improve skills with Outlook, Word and Excel.
• Demonstrate meticulous attention to detail in following procedures, preparing written documentation, and completing QA/QC activities.
• Work independently and enforce compliance goals and requirements as determine by QA Management.
• Ability to work in a high paced, multi-tasked environment.
• Have a strong affinity for team work.
• Self-starter that is hard working with demonstrated interpersonal and communication skill.
• Strong organizational skills.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee in order 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 sit, use hands and fingers, handle or feel, reach with hands and arms, and talk and hear. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 10 pounds and frequently lift and/or move up to 25 pounds

KNOWLEDGE,SKILLS and ABILITIES:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Interpersonal Skills – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
• Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Participates in meetings.
• Written Communication – Writes clearly and informatively; Able to read and interpret written information.
• Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.
• Change Management – Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• Leadership – Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen – Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization’s goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Cost Consciousness – Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization’s goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Strategic Thinking – Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Safety and Security – Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality – Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
• Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.