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Sr. Quality Assurance Specialist

Siegfried USA

  • Pennsville, New Jersey
  • 30+ days ago
  • $82,000–$110,000 Per Year
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Skills

  • Active Pharmaceutical Ingredient (API)unmatched
  • Application Programming Interface (API)unmatched
  • Biotech and Pharmaceuticalunmatched
  • Communication Skillsunmatched
  • Corporate Policiesunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Dosage Formsunmatched
  • Environmental Monitoringunmatched
  • Establish Prioritiesunmatched
  • External Auditunmatched
  • Internal Auditunmatched
  • Legalunmatched
  • Manufacturingunmatched
  • Manufacturing Operationsunmatched
  • Product Reviewsunmatched
  • Project/Program Managementunmatched
  • Quality Assuranceunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Safety Standardsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Sustainabilityunmatched
  • System Validationunmatched
  • Systems Analysisunmatched
  • Team Playerunmatched
  • Time Managementunmatched

Description

"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,approveand tracksexecuted production records.

  • Reviewsand approvesproductionand QCinvestigations.

  • Reviewslab sample results and manufacturing records relatedto qualification/validation activities.

  • Conducts, write,andreviewsquality related investigations asappropriate.

  • Reviewsand approvesMaster Production Records.

  • Responsible for cGMP complianceofassigned manufacturing operations / areas.

  • CompletesQMSitems as assigned.

  • Is responsible forthe conditional / final release of materials.

  • Hosts customer and internal audits, as needed

  • Conductinternal and external audits, as needed

  • Participates in inspections by regulatory authorities

  • Writes and reviews Annual Product Reviews/Product Quality Reviews

  • Writes andreviewsProduct Validation / Qualification / Assessments documents.

  • WritesandreviewsEquipment Qualifications / Assessments documents.

  • Writes andreviewsComputerized Systems Validations / Assessments documents.

  • Reviews,evaluatesand approvesminor equipment changes.

  • ConductsGMP inspections.

  • Conducts environmental monitoring.

  • ReviewsandapprovesCMC sections ofDMFs asappropriate.

  • MaintainsQA databases for products / equipment asappropriate.

  • Adheres to personal moral, ethical, legal, and behavioral conductthatis in compliance withthe SiegfriedCode of Conduct.

  • Adheresto all applicable SHE and cGMPregulationse.g.ICH Q7, FDA, 21 CFR 210 and 211, etc.

EDUCATION AND EXPERIENCE:

  • A BA/BS degree inmicrobiology, biology, chemistry, orengineeringand3-5years of experience inQAin apharmaceutical manufacturing environment, or an equivalent combination of education and experience.

  • Thorough knowledge of cGMPin active pharmaceutical ingredient (API) manufacturingispreferable.

Your Benefits: 

OTHER REQUIREMENTS:

  • Musthave excellent communication skills.

  • Must be conscientious anddetail oriented.

  • Must have excellent computer skills (MS Office365). 

  • Must be a team player.

  • Must be ableto self-manage daily work and set priorities. 

  • Must be able to manage projects and prioritize appropriately.

  • Mustbe able to adhere to deadlines.

  • The salary for this role is anticipated to be between $82,000 and $110,000

Siegfried USA, LLCwill explore and provide reasonable accommodations toassistany qualified individual with a disability in performing the essential functions of his/her job.  Please speak with HR should you requirean accommodationor have any questions.

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry. 

Numbers & Facts

LocationPennsville, New Jersey
Salary$82,000–$110,000 Per Year

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