Specialist II, Quality Assurance

The Quality Assurance Specialist II will implement maintain and champion the quality system and its components. They will operate alongside but report separately to laboratory operations to provide quality assurance oversight to the testing process.

• Responsible for the quality system and its implementation.
• Maintains knowledge of ISO GMP and other quality systems as required by clients and regulatory authorities.
• Responsible for equipment verification and maintenance
• Signs or ensures signing of required forms and checklists
• Initiate distribute and review all controlled documents. Update documents as required. Ensure that no deviations are made without proper authorization and documentation.
• Ensures process nonconformances (PNC) deviations change controls and other Quality Assurance tools are appropriately completed and tracked.
• Assist Operations with training records ensuring all staff training is accurate and up to date.
• Manage proficiency program participation and trending to ensure compliance to client regulatory and internal requirements.
• Identify and ensure implementation of preventive actions.
• Assist with accreditation renewal client audits and internal auditing activities.
• Provide training and support to Quality Assurance I.

Qualifications :

• Bachelors Degree or equivalent work experience Required
• 5-7 years related experience or 4 years experiences with an advanced degree (M.S. or Ph.D.) Required
• Excellent organizational abilities attention to detail interpersonal skills and multi-tasking capability
• Knowledge of ISO GMP and other quality systems
• Prior experience with quality systems (document control CAPA OOS etc.)

Additional Information :

Our Benefits

We care about your total well-being and will support you with the following subject to your location and role.

• Health: Medical dental and vision insurance life insurance employee wellness programs
• Wealth: Competitive pay 401(k) with company match (immediate vesting upon enrollment) employee referral program annual bonus target
• Happiness:
  • Professional Growth: Online training courses virtual and classroom development experiences tuition reimbursement program
  • Work-Life Balance: Paid-time off (vacation sick company holidays floating holidays volunteer time)

SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.

This job description should not be construed as an exhaustive statement of duties responsibilities or requirements but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability please call for assistance and leave a message. You will receive a call back.  Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Remote Work :

No

Employment Type :

Full-time