Senior Quality Assurance Specialist

North American Science Associates • Saint Paul, MN

2d • $75,000 - $85,000

About The Position

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: Initiates and drives QA employee onboard training. Acts as new hire training coordinator. Assists in creation of monthly auditor lab schedule. Provides training to peers. Conducts GDP training for all new employees. Conducts reviews of training binders. Initiates and collaborates on document revisions including training tools. Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP). Performs critical phase audits and appropriately documents findings. Reviews final reports (GLP), batch records (cGMP), Certificates of Analysis/ Certificates of Testing (GMP). Leads review activities for complex reports. Utilizes SME skills through serving as a peer mentor and assisting in study design. Participates in external audits, as needed. Contributes to all phases (initiation, review, and approval) of investigations and VOE actions. Collaborates on document revisions. Serves as Queue Manager on a rotating basis. Other duties as assigned. Qualifications & Technical Competencies: Minimum 5 years relevant experience or equivalent Bachelor’s Degree or equivalent Scientific background preferred GLP or ISO 17025 certification preferred Knowledge / Skills / Abilities: Thorough understanding of Good Laboratory Practices and current Good Manufacturing Practices. Proficient training, planning, resource and project management skills Proficient Oral & Written communication skills Strong coaching and mentoring skills needed to facilitate knowledge sharing Need to be able to read, write and understand English Proficient in Microsoft (Excel, Word, Outlook) Pay range: $75k-85k Working Conditions: Must be able to work in an office environment with minimal noise conditions. Must be able to work in Lab setting with exposure to Animals/ Biohazards / Chemicals Must not have animal allergies to applicable species in this facility Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Ability to stand/ sit/ walk for long periods of time Ability to Lift 10 lbs routinely Ability to crouch, bend, twist, and reach Ability to push/pull 10 lbs occasionally Clarity of vision Ability to identify and distinguish colors- As evidenced by passing a color blindness screening test Must be able to perform activities with repetitive motions Ability to work in variable temperatures high to freezing Inside working conditions Pay Range Minimum: $54,400.00 Pay Range Target: $85,000.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.

Requirements

• Minimum 5 years relevant experience or equivalent
• Bachelor’s Degree or equivalent
• Thorough understanding of Good Laboratory Practices and current Good Manufacturing Practices.
• Proficient training, planning, resource and project management skills
• Proficient Oral & Written communication skills
• Strong coaching and mentoring skills needed to facilitate knowledge sharing
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with exposure to Animals/ Biohazards / Chemicals
• Must not have animal allergies to applicable species in this facility
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand/ sit/ walk for long periods of time
• Ability to Lift 10 lbs routinely
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 10 lbs occasionally
• Clarity of vision
• Ability to identify and distinguish colors- As evidenced by passing a color blindness screening test
• Must be able to perform activities with repetitive motions
• Ability to work in variable temperatures high to freezing
• Inside working conditions

Nice To Haves

• Scientific background preferred
• GLP or ISO 17025 certification preferred

Responsibilities

• Initiates and drives QA employee onboard training.
• Acts as new hire training coordinator.
• Assists in creation of monthly auditor lab schedule.
• Provides training to peers.
• Conducts GDP training for all new employees.
• Conducts reviews of training binders.
• Initiates and collaborates on document revisions including training tools.
• Ensures compliance to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
• Performs critical phase audits and appropriately documents findings.
• Reviews final reports (GLP), batch records (cGMP), Certificates of Analysis/ Certificates of Testing (GMP).
• Leads review activities for complex reports.
• Utilizes SME skills through serving as a peer mentor and assisting in study design.
• Participates in external audits, as needed.
• Contributes to all phases (initiation, review, and approval) of investigations and VOE actions.
• Collaborates on document revisions.
• Serves as Queue Manager on a rotating basis.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level