As part of its global Quality Transformation Plan (QTP), XXX is strengthening its Quality and Validation capabilities across several manufacturing sites following regulatory remediation and quality improvement initiatives.
To support these activities in the United States. We are looking for experienced consultants to reinforce local teams on key Quality and Qualification workstreams. The consultants will work directly on-site with manufacturing, engineering and quality teams to support remediation, compliance and operational excellence activities.
Missions:
Key responsibilities:
Support visual inspection process improvements and remediation activities.
Review and update SOPs and working procedures.
Support GMP compliance and inspection readiness initiatives.
Participate in investigations, CAPA activities and quality assessments.
Ensure compliance with regulatory requirements for injectable products.
Collaborate with Quality Operations and Manufacturing teams.
Required skills:
Visual Inspection
Sterile Manufacturing
Injectable Products
GMP Compliance
Inspection Readiness
SOP Writing
CAPA & Investigations
The pay range that the employer in good faith reasonably expects to pay for this position is $30.51/hour - $47.67/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
