- CAPA (Corrective and Preventative) Management: Maintain CAPA Log including customer's complaints and incidents; Work with department managers/assigned parties to write action plans when needed; Review and approve root causes and action plans, gather evidence, verify effectiveness; Work directly with key accounts on customer complaints and quality concerns; Review trends and communicate concerns.
- Management of Change: Act as the QA representative in pre-submission meeting and assist initiator / project owner in completing the MOC form in meeting.; Maintain status updates on MOC Log, obtain any necessary approvals, follow up with initiators / project owners on status action items, and verify effectiveness; Write customer notification letters and notify internal customers of change; Work with Marketing Department for notification of external customers.
- Deviation Program: Responsible for issuance of Deviation Numbers at CT and KY Site; Maintain documentation, provide subject matter expertise and provide approvals; Management of Triennial Documentation Review; Ensure compliance with the Triennial Documentation Review process.; Process documents through the Change Control Process.; Includes Yearly Visual Aid Audit facilitation
- Internal Auditor: Conduct Internal Audit, write report, distribute report and assign corrective actions if necessary.
- Change Control Process: Manage and Process Change Controls for Standard Operating Procedures, Work Instructions and Forms. Includes receiving appropriate approvals, reviewing for applicability, maintaining logs and closing change control completely.
- New Item Set Up Procedure: Manage and Process Change Controls for New Product Set Up, Private label opportunities and new package sizes; Set up for all SC&I which includes CT, KY, and Ireland Legal Entities.
- Quality Management Related Trainings: Create and administer training associated with the QMS and other Quality System related topics; Manage and execute any assigned projects needed to support business growth; Create Project Plan and document through the Change Control Process.
- Bachelor's degree in science or related field
- ISO 9001 and cGMP experience preferred
- Proficient in Excel and Word
- Strong communication and interpersonal skills
- Proven work experience and qualifications as a collaborative and agile team member
- Strong organization and time-management skills
- Proven ability to multi-task and pay attention to detail
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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Quality Assurance Specialist - Brookfield, United States - Actalent
Description
Description:
Skills: administrative skills, computer data entry, document control, quality assurance, manufacturing
Additional Skills & Qualifications:
Experience Level: Entry Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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