Quality Assurance Specialist I - Therapeutics Job at Katalyst CRO, Petaluma, CA

ZlA0cGtKdnNHemdvK0JnNjRZVlpxOWN6WlE9PQ==
  • Katalyst CRO
  • Petaluma, CA

Job Description

Job Description

**Roles and Responsibilities**

  • Quality & Compliance: Complete all activities adhering strictly to quality and regulatory standards and procedures. Foster a focus on quality and strive for excellence in every task.
  • Continuous Improvement: Cultivate a culture of continuous improvement by demonstrating industrial excellence methodologies, lean metrics, and key performance indicators.
  • Raw Material Release: Review of incoming Raw Material records for completeness and disposition
  • Batch Review: Perform technical review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. Review batch records, summary reports and other release documentation as necessary.
  • Accountability: Support employees and departments by communicating clearly and acting. Ensure proactive communication with customers for timely issue resolution and partner concern. Facilitate cross-functional communication effectively.
  • Environment Health & Safety: Ensure compliance with LGC’s safety and environmental guidelines.
  • Quality Systems: Support the following quality processes: Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation.
  • Quality Operations: Support the following quality processes: Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation
  • Other Duties as mandated by site priorities and Quality, Business, or Safety requirement.

Qualifications

**Qualifications**

Minimum Qualifications

  • A 4-year college degree in Engineering, Chemistry, Biochemistry, Biological Sciences, or a related field, or an equivalent combination of education, training, and industry experience.
  • Need 1- 4 years in Manufacturing, Quality Control, or Quality Assurance in pharmaceutical settings.
  • Proficiency in MS Office software applications (Word, Excel, PowerPoint, Outlook).
  • Strong technical writing and interpersonal skills.

Preferred Qualifications

  • Experience in CAPA, Deviation and Nonconformance reporting, internal auditing, and supplier management.
  • Extensive knowledge of ICH, FDA/EMA regulations for Active Pharmaceutical Ingredients and/or Finished pharmaceuticals.
  • Lead auditor training and/or certification.

**Proficiencies & Behaviours**

  • Outstanding interpersonal and communication skills.
  • Resonates with and operates in line with LGC’s core values: Passion, Curiosity, Integrity, Brilliance, and Respect.
  • Promotes teamwork and dedication to achieving goals and deliverables.

**Physical Requirements**

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Additional Information

  • The typical pay range for this role is** :
  • Minimum:** $ 32.50 per hour USD
  • Maximum** : $ 35.00 per hour USD

This range represents the low and high end of the anticipated salary range for the California-based position. The actual base salary will depend on several factors such as experience, skills, and location.

**About LGC**

LGC is a top life science tools company, offering important components for key industries.

Our Values

  • PASSION
  • CURIOSITY
  • INTEGRITY
  • BRILLIANCE
  • RESPECT

Equal Opportunities

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or birthing parent, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

For more information about LGC, please visit our website

\#scienceforasaferworld

Job Tags

Hourly pay,

Similar Jobs

ACHE of Indiana

Travel Cardiac Cath Lab Registered Nurse - $3,213 per week Job at ACHE of Indiana

Seeking a travel RN for a 13-week assignment in Lynwood, California, specializing in Cardiac Cath Lab. Start ASAP, with 40 hours/week on 10-hour day shifts. Requires 1-2 years of experience in the Cath Lab. Traveling offers diverse professional and personal growth... 

BROWN DESIGN INC

Fashion/Internship Assistant Job at BROWN DESIGN INC

Seeking Fashion / Internship Assistant. Successful candidates will exude great pride in their work, welcome challenging assignments, viewing them as opportunities for continued learning and personal growth, be extremely detail orientated, have excellent communication skills... 

Novo Nordisk

Pharma Field Sales - District Business Manager - Langhorne Pennsylvania Job at Novo Nordisk

 ...About the Department The Diabetes Sales Team leads the US sales efforts for Novo...  ...budget and business plans. This is an entry level district business manager position....  ...D required ~5+ years of progressive pharmaceutical or healthcare sales experience required... 

Citizens

Private Wealth Management, Transition Operations Specialist Job at Citizens

DescriptionCitizens Private Wealth is charging forward with bold momentum-accelerating our strategy to elevate Wealth Management, scale Business Banking, grow deposits, and expand into high-potential markets nationwide in partnership with our Private Banking teams.As... 

Zenex Staffing Solutions Pvt Ltd.

Registered Nurse - NICU Job at Zenex Staffing Solutions Pvt Ltd.

NICU RN Hard-Stops: No Travel Pairs 1st Time Travelers OK Start: ASAP Shift: 3x12 days Certs: BLS, NRP Experience: Level III experience Locals accepted: No Pending License accepted: No RTO restrictions: ALL RTO must be included at time of submission. Approval will be based...