Sr. Quality Assurance Specialist

Siegfried Ltd; Pennsville Township (NJ); Vor Ort; USD 82.000 - 110.000; Vollzeit

Zusammenfassung

Siegfried Ltd in Pennsville Township is looking for a Sr. Quality Assurance Specialist. The role involves ensuring compliance with regulatory requirements and Good Manufacturing Practices while engaging in complex investigations and documentation related to quality assurance.

Ideal candidates will have a BA/BS in a related field and 3-5 years of QA experience in pharmaceuticals. The position offers a competitive salary between $82,000 and $110,000 and opportunities for professional growth.

Qualifikationen

• Must have excellent communication skills.
• Must be conscientious and detail-oriented.
• Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.

Aufgaben

• Assures compliance with regulatory requirements and current Good Manufacturing Practices.
• Reviews and approves production and QC investigations.
• Conducts internal and external audits as needed.
• Writes and reviews Quality-related documentation.

Kenntnisse

Excellent communication skills

Detail oriented

Computer skills (MS Office 365)

Team player

Project management

Ausbildung

BA/BS degree in microbiology, biology, chemistry, or engineering

3-5 years of experience in QA in a pharmaceutical manufacturing environment

Jobbeschreibung

## Sr. Quality Assurance SpecialistApplylocations: Pennsville, NJtime type: Full timeposted on: Posted Yesterdayjob requisition id: R26\_439"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.**Your Role:**The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.**Your Profile:****ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES**:* Reviews, approve and tracks executed production records.* Reviews and approves production and QC investigations.* Reviews lab sample results and manufacturing records related to qualification/validation activities.* Conducts, write, and reviews quality related investigations as appropriate.* Reviews and approves Master Production Records.* Responsible for cGMP compliance of assigned manufacturing operations / areas.* Completes QMS items as assigned.* Is responsible for the conditional / final release of materials.* Hosts customer and internal audits, as needed* Conduct internal and external audits, as needed* Participates in inspections by regulatory authorities* Writes and reviews Annual Product Reviews/Product Quality Reviews* Writes and reviews Product Validation / Qualification / Assessments documents.* Writes and reviews Equipment Qualifications / Assessments documents.* Writes and reviews Computerized Systems Validations / Assessments documents.* Reviews, evaluates and approves minor equipment changes.* Conducts GMP inspections.* Conducts environmental monitoring.* Reviews and approves CMC sections of DMFs as appropriate.* Maintains QA databases for products / equipment as appropriate.* Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.* Adheres to all applicable SHE and cGMP regulations e.g. ICH Q7, FDA, 21 CFR 210 and 211, etc.**EDUCATION AND EXPERIENCE:*** A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in QA in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.* Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.**Your Benefits:****OTHER REQUIREMENTS:*** Must have excellent communication skills.* Must be conscientious and detail oriented.* Must have excellent computer skills (MS Office 365).* Must be a team player.* Must be able to self-manage daily work and set priorities.* Must be able to manage projects and prioritize appropriately.* Must be able to adhere to deadlines.* The salary for this role is anticipated to be between $82,000 and $110,000Siegfried USA, LLC will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.