SUMMARY OF POSITION:

The QA Specialist II must oversee and maintain compliance/regulatory activities as well as day-to-day Quality functions in support of overall quality systems and domestic packaging operations. The candidate must be versatile, independent, an effective communicator and must have strong leadership skills.  This individual will utilize QA experience to provide support to Quality Assurance leadership.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Development, review and approval of product specifications.
• Development, review and approval of Master Batch Records.
• Review and release of finished product packaged domestically.
• Support Quality Assurance Manager in qualification and evaluation of vendors.
• Initiation and follow-through for controlled document Change Controls.
• Participation in development and review of facility qualification and maintenance documents.
• Participation in development and review of equipment qualification and maintenance documents.
• Participation in IT validation projects.
• Procedure development, update, distribution and implementation.
• Training of personnel in procedures and development of training programs in support of the Quality Assurance Manager.
• Initiation of investigations and deviations, root cause analysis, recommend and implement CAPA.
• Record, review, report, investigate, and file product quality complaints.
• Collaborate with Boiron S.A. counterparts in France.
• Conduct internal audits, identify non-conformances, recommend and implement CAPA.
• Conduct vendor audits as requested.
• Support third party audit programs.
• Actively support regulatory inspections.
• Inspect and process product returns as requested.
• Inspection of product in support of investigations as requested.
• QA Documentation retention, filing and maintenance.
• Maintain open communication with branch teams and vendors to resolve challenges.
• All other duties as assigned.

REQUIREMENTS:

• Education: Bachelor’s degree in Life Science or related field or equivalent experience.
• Minimum of (4) four years’ experience in QA/QC with FDA regulations and pharmaceutical cGMPs.
• Knowledge of Microsoft Office software with ability to use Word and Excel spreadsheets with graphing.
• Demonstrate meticulous attention to detail in following procedures, preparing written documentation, and completing QA/QC activities.
• Work independently at a high level and enforce compliance goals and requirements.
• Ability to work in a high paced, multi-tasked environment.
• Have a strong affinity for teamwork.
• Self-starter that is hard working with interpersonal and communication skills.
• Strong organizational and technical skills.
• Ability to travel 10% domestic primarily; this may include overnight and/or weekend travel.

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 accommodation 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 accommodation 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.
• Customer Service – Responds promptly to customer needs; Responds to requests for service and assistance; Meets commitments.
• 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.
• Ethics – Treats people with respect; 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.
• Strategic Thinking – Adapts strategy to changing conditions.
• Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Sets goals and objectives.
• 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.
• Adaptability – Adapts to changes in the work environment; 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.