Quality Assurance (Qa) Specialist

Summary

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.

We offer competitive starting compensation, but we are not held back by rigid compensation grids and rules. The harder and smarter we work, the better we all do financially.

We also offer a competitive benefits plan to ensure our employees have the safety net we all need to be able to defend ourselves and our families from the unexpected. See below for a comprehensive list of employee benefits:

• Up to 22 weeks of 90% salary top-up for maternity and up to 5 weeks top-up for paternity
• Free coverage for premium healthcare benefits through Blue Cross
• Company events and monthly lunches
• RRSP contribution matching program with free access to financial advisor
• Conference/travel opportunities for Technical Staff
• Subsidized downtown parking or transit reimbursement
• COSTCO membership and professional membership coverage
• Culture that supports continuous employee growth and encourages collaboration
• Extensive holiday list
• Generous vacation accrual and sick time policies
• Continuing education support
• A friendly,diverse andnurturing environment
• Downtown location with views of the Halifax harbour
• Free in-house snacks and coffee
• Flexible working hours in an innovative and fast paced industry
• Bonus programs

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

• Other responsibilities as assigned.
• Implement and execute inspection, testing, and evaluation methods to ensure that operations adhere to required quality standards.
• Participate in external audits when they arise.
• Perform or oversee internal quality audits; prepare site and staff for Health Canada and other regulatory inspections.
• Follow the safety rules and housekeeping principles to ensure all working areas are clean and safe
• Periodically verify the qualification and maintenance of premise and equipment.
• 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.

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

• Self-motivated
• Organized
• Proven ability to identify quality issues and proactively resolve issues in a team setting.
• Ability to work well in a collaborative environment or independently
• Creative and innovative thinking
• Ability to use Microsoft office software is a must
• Experience working in a GMP regulated environment
• Excellent organizational and time management skills

Closing Date

Open until filled.

Contact information

Please e-mail your CV and cover letter [email protected] why you are an ideal candidate.