Sr. Quality Assurance Specialist

Location: Pennsville

## Sr. Quality Assurance Specialist Apply locations:
Pennsville, NJtime type:
Full time posted on:
Posted Yesterday job requisition :
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 $110,000

Siegfried 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.
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