Quality Services Specialist

DEPARTMENT: Quality

POSITION SUMMARY: Primarily supports commercial and customer quality document requests.

REPORTS TO: Senior Manager Quality and Regulatory Europe

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Develop Goals and Motivations for Excellence in Quality Support Services:

· Place the interests of the Commercial Team and the Customer first; our success depends on their success.

· Be highly responsive and timely to the Commercial Team and Customer Key Accounts.

· Meet deadlines; communicate status and delays to the Team and customers proactively.

· Pursue an unrelenting quest for quality; use speed and simplicity to achieve goals.

· Communicate pleasantly and effectively.

· Demonstrate professional etiquette and courtesy when interfacing with customers.

· Conduct oneself with the highest level of integrity and business ethics.

· Commit to teamwork; seek out and use the ideas and skills of all colleagues.

· Reach for the highest standards of performance; show a passion for winning.

Commercial Team Support Function:

· Curate any and all Commercial Team and direct Customer Requests:

· Process information received from Commercial Team personnel via SFDC or the shared email inbox.

· Manage and prioritize information to ensure timely delivery as per the established SLAs.

· Organize and maintain documentation received in the Quality SharePoint and/or MasterControl and conduct follow-up, as applicable.

· Liaise with internal and external stakeholders to resolve customer requests.

· Complies with and adheres to all regulatory compliance areas, policies and procedures.

· Identifies and implements “best practices” in Quality Services.

· Keep all document logs and SFDC task queue up-to-date.

· Review weekly tasks and responsibilities with direct supervisor.

· Coordinate the review and signature of CDA/NDAs and QAAs.

· Coordinate the completion of customer questionnaires, declarations and statements.

· Update Actylis Statements, Declaration and documents including but not limited to: TSE/BSE, Elemental Impurities, Residual Solvents, GMO, Allergens, Melamine, Prop 65, etc.

· Respond to Product Information Requests including but not limited to: Specifications, Typical COAs, Certificate of Origin, Test Methods, Shelf-Life Letter, Manufacturer and Supply Chain Information, Packaging Specification/Information, Storage Conditions Statement, Stability Statement, Stability Data, Example Label, etc.

· Manage product Information packages based on ICH and/or IPEC guidelines.

· Act as liaison in organizing the timing and set-up of customer audits

EDUCATION/EXPERIENCE :

· Undergraduate degree (Chemistry or related field)

· Quality Systems Knowledge (ISO and GMP) - 2 years experience

SPECIFIC KNOWLEDGE, SKILLS, LICENSES, CERTIFICATIONS, ETC.:

· Strong communication (oral and written)

· Accurately apply due dates

· Meet deadlines,

· complete tasks

· Sense of urgency

· Ability to make sound decisions

· Ability to multi-tasks

· Ability to read, understand and apply complex instructions/regulations

· Stress-management

· Computer literate

· Self-motivated, have initiative

· Analytical

· Ability to work independently

· Time-management

· Attention to detail

SUPERVISORY RESPONSIBILITIES:

N/A

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made where necessary. The noise level in the work environment is usually moderate. Employee is home office based and must have adequate space and tools to perform their duties.

Job Types: Full-time, Permanent

Expected hours: 40 per week

Additional pay:

• Yearly bonus

Benefits:

• Company pension
• On-site parking
• Private medical insurance
• Sick pay
• Work from home

Schedule:

• Monday to Friday

Application question(s):

• What is your notice period?
• What are your salary expectations?

Education:

• Bachelors (required)

Experience:

• Quality systems: 2 years (required)

Work authorisation:

• Ireland (required)

Work Location: Remote