The Role

QA Specialist

POSITION SCOPE

As a member of the Quality Team, you will ensure adherence to ISO 9001 and cGMP standards by reviewing documentation, approving QC data, providing labels, and facilitating RCA/CAPA closure and complaint resolution. You will also support quality system improvements, communicate effectively with internal and external stakeholders, and collaborate with the QA team to prioritize tasks and provide cross-training.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Key responsibilities include, but are not limited to the following:

· Answer customer questionnaires, review supplier quality agreements, and provide quality statements in a timely manner with good record keeping within the CRM.

· Be an active Quality System team member participating in timely CAPA closure and complaint investigation and resolution by supporting cross functional work and high standards of completion.

· Review lab data, provide COA updates, write quality statements, analyze and present data, and perform other quality responsibilities as required.

· Work with all departments as a technical writer in updating all documentation including procedures, work instructions, and forms to meet the requirements of ISO 9001.

· Audit as a member of the site internal audit team to maintain ISO 9001 and other certifications and meet cGMP requirements. Write audit reports and track internal audits for the site. Ensure the appropriate functional owner responds to findings with RCA and planned CAPAs, that actions are closed in a timely manner, and that you verify effectiveness.

· Participate in external audits, ensuring timely completion of any CAPA responses to non-conformances.

· Utilize the CRM and ERP LIMS systems for data entry, review, and communications, and contribute to maintenance of the IT systems related to Quality.

· Contribute to reviews and approvals of specifications, as well as data review to verify that materials meet specifications.

· Work with the QC laboratory and other functions to ensure quality, improve processes, and ship products to our customers.

Note: The duties listed above are not all inclusive and may be subject to periodic updating or revision.

The Ideal Candidate

Desired Background

Bachelor’s degree in quality management, chemistry, or related field, and a minimum of 2 years of relevant QA experience.

Knowledge, Skills & Talents

More specifically, we would seek the following attributes and competencies for the position:

• Quality Management Systems literate i.e. ISO 9001, cGMPs, MoCRA, etc.

• Possess experience communicating positively with customers, suppliers, and cross functionally, and the ability to work well with others.

• Excellent technical writing skills based on good listening, understanding, and working across functions.

• Good organization and documentation skills.

• Computer competence to include email, LIMS, CRM, ERP, MS Office, and SharePoint.

Job Type: Full-time

Benefits:

• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 2 years (Required)

Work Location: In person