QA Documentation Specialist

5 days ago

Burlington, United States Quality Packaging Specialists Int’l, LLC Full time

QA Document Special

t _Overview:_ The Quality As

rance Doc
- ntation Special
- will be respons
- e for reviewing
- verifying doc
- nt records to
- sure the documen

ation complies wi
- regula

ions and
- ernal qualit
- ontrol pr
- ices. The princi
- responsibility of

every employe
- s to aid
- the production of supe
- r-qual
- products

Responsibil
- es:_
- Maintain documentation and rec
- s under Good Documentation Pr

ices industry best pract

es and regulatory requirements to ensure compliance.
- Participate in audits, both internal and external and support any corrective actions or process improvements identified during the audit process.
- Organize charts for the Quality Assurance Team and maintain record confidentiality.
- Review batch records for compliance with specifications and regulations.
- Address deviations and manage documentation for rejections.
- Analyze lab results and coordinate timely documentation for finished goods release.
- Collaborate with other departments, including Warehouse, Operations, and Customer Service to ensure efficiency and compliance with industry standards and applicable regulations.
- Oversee and manage Destruction Processes and related SOPs.
- Review receiving paperwork, release from Warehouse inventory management system, and ensure compliance with special receiving instructions for specific clients.
- Download and escalate temperature monitoring data logger reports with receiving documents to Client Services and save them into client-specific folders.
- Review and file all receivers, receipt-by-date reports, and job jackets.
- Oversee pest control documentation, signing off on monthly vendor-supplied documents.
- Coordinate archiving of year-end files, receivers, job jackets, SOD waves, and production waves.
- Assist on the production floor and address any issues or concerns raised by QA Associates.
- Other duties as assigned. _Qualifications/Educational Requirements _
- High School Diploma or equivalent, or equivalent combination of education and experience.
- Minimum 1 year of experience in a packaging environment or Quality role.
- Familiar with cGMP practices and QA guidelines and protocols
- Minimum 1 year of experience in a GMP or FDA-regulated industry with Good Documentation Practices
- Minimum 2 years of experience in document review or laboratory testing.
- Excellent Oral and Written communication skills
- Excellent oral and written communication skills
- Strong Data Entry Skills and Organizational abilities
- Ability to read, write, and understand English
- Proficiency in Microsoft Office.
- Attention to detail and problem-solving abilities.
- Ability to work well independently or within a team environment
- Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment. Pay: $21.30 - $25.66 per hour Benefits:

- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance Experience level:

- 1 year Schedule:

- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed Work setting:

- In-person
- Manufacturing facility
- Office
- Warehouse Experience:

- Quality assurance: 1 year (preferred)
- Packaging: 1 year (preferred) Work Location: In person

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