Quality Assurance Specialist

Contenido de trabajo

Job Description

Solid State Pharma Inc. is a pharmaceutical research company and leader in the delivery of crystallization engineering and solid state science services. SPPI has experienced great success with the workflows that have been developed by combining fundamentals of crystallization and solid form science with years of experience and high throughput techniques. SSPI research is a key part of pharmaceutical development particularly on crystallization engineering, polymorph screening, salt screening, co-crystal screening, pre-formulation, pre-clinical stability studies, chiral resolution, polymorph quantification, converting amorphous material to crystalline solid, chemical and crystallization process modeling and characterization.

Summary

The Quality Assurance (QA) Specialist is a key contributor to the operational success and capabilities growth of SSPI. The individual will be reporting to associate director of Quality and Admin. The Quality Assurance Specialist will provide quality oversight of the GMP operations at SSPI, working along with the established Quality Management System to support the GMP testing and methods development and qualification. In addition to quality oversight, duties include development, review and approval of certain GMP documents that are necessary for ensuring compliance with FDA, Health Canada and other applicable regulatory agencies.

Job Responsibility

· Participate in designing, writing and implementing SOPs and documents in compliance with GMP standards, including but not limited to protocols for qualification and validation.

· Ensure that documentation, complaints, deviations, non-conformances, investigations, corrective and preventative actions, and change control are performed according to quality and regulatory requirements.

· Implement and execute inspection, testing, and evaluation methods to ensure that operations adhere to required quality standards.

· Perform or oversee internal quality audits; prepare site and staff for Health Canada and other regulatory inspections.

· Participate in external audits when they arise.

· Periodically verify the qualification and maintenance of premise and equipment.

· Follow the safety rules and housekeeping principles to ensure all working areas are clean and safe

· Other responsibilities as assigned.

Education & Experience

Minimum BSc (3-7 years related experience) or MSc (2-5 years). A science degree from a Canadian university or from an institution recognized as equivalent by a Canadian university or Canadian accreditation body, is a must. Experience working in a GMP regulated environment.

Skills

· Experience working in a GMP regulated environment

· Excellent organizational and time management skills

· Proven ability to identify quality issues and proactively resolve issues in a team setting.

· Ability to work well in a collaborative environment or independently

· Organized

· Self-motivated

· Creative and innovative thinking

· Ability to use Microsoft office software is a must

Closing Date

Open until filled

Job Type: Full-time

Benefits:

• Commuter benefits
• Company events
• Dental care
• Disability insurance
• Discounted or free food
• Extended health care
• Life insurance
• Paid time off
• RRSP match
• Store discount
• Tuition reimbursement
• Vision care

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Halifax, NS B3M 3J5: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor’s Degree (preferred)

Experience:

• quality assurance: 2 years (required)

Work Location: In person