Senior Specialist, Quality Assurance Job Listing at Alternative Resources Company in Somers, NY
This position is responsible for facilitating the review and approval of laboratory investigation. This position will also oversee the review of corrective and preventative action (CAPA) plan to assure completion. This position will also review and approve the laboratory test protocols, report and method.
Essential Duties and Responsibilities:
• Will be responsible for review and approval of analytical method validation program and product development data to support drug applications.
• Will be responsible for the review and approval of the laboratory deviation.
• Determine and define the root cause for laboratory investigation.
• Facilitate meaningful CAPA plan with the responsible parties, including reasonable completion dates.
• This position requires an individual well versed in cGMP’s, laboratory operation and a solid understanding of method development and validation.
• Member of Quality Improvement teams as needed to address Quality / process issues. Lead quality process improvements.
• Participate in QRB and other compliance meetings for ensuring compliance requirements are met.
• This position must possess interpersonal skill for effective interaction with other departments.
• Number of exempt employees supervised: 0
• Number of non- exempt employees supervised: 0
Education and or Experience:
• BS, MS or PhD in Chemistry or related discipline
• 5 to 7 years of experience in pharmaceutical laboratory with a minimum of 5 years of method development and validation experience for solid dose products.
Competencies: To perform the job successfully, an individual should demonstrate the following competencies:
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• 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.
• 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.
• 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.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• 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.
• 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.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
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