MCS Manufacturing Sr. Associate Job at BioPharma Consulting JAD Group, Thousand Oaks, CA

NzlaVUIySGt6NDA3K2dOQmtuZytEdXQwUlE9PQ==
  • BioPharma Consulting JAD Group
  • Thousand Oaks, CA

Job Description

We are seeking a Senior Manufacturing Associate to support the B7 restart of Epogen production by leading and executing Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs). This role is ideal for candidates with a GMP background, deviation writing experience, and a continuous improvement mindset. You will collaborate with cross-functional teams and utilize project management skills to ensure compliance and operational excellence.
Responsibilities

  • Own and execute CAPAs and EVs related to Epogen production, ensuring timely completion.
  • Support continuous improvement initiatives to enhance efficiency, quality, and safety.
  • Utilize project management tools to track, monitor, and report progress.
  • Collaborate with stakeholders across quality, engineering, validation, and regulatory teams.
  • Maintain compliance with cGMP, SOPs, and EHS policies.
  • Contribute to risk management and safety culture improvements.

Skills:

  • Strong analytical, problem-solving, and decision-making skills.
  • Ability to work independently and collaboratively, with a high level of initiative and accountability.
  • Excellent verbal and written communication skills, with attention to detail and accuracy.
  • Experience with project management tools and techniques, such as MS Project, Agile, Smartsheet.

Requirements

  • Master’s degree + 2 years of experience OR
  • Bachelor’s degree + 3 years of experience OR
  • Associate’s degree + 5 years of experience OR
  • High school diploma/GED + 10 years of experience
  • Background in GMP manufacturing and deviation writing
  • Experience with CAPA/EV ownership using Trackwise or similar quality systems
  • Experience with Veeva Vault, Smartsheet, Trackwise, MS Project, Agile

Job Tags

Contract work,

Similar Jobs

Concord Academy

English Teacher Leave Coverage Job at Concord Academy

 ...commitment to creating and maintaining a diverse and equitable school community. Successful candidates will demonstrate a strong desire...  ...Academy Concord Academy is an independent, co-educational boarding and day school renowned for its world-class faculty, passionate... 

Alta Strada - Embassy Row

Executive Chef Job at Alta Strada - Embassy Row

 ...Italian favorite ALTA STRADA has moved and is hiring askilled and passionateEXECUTIVE CHEF to join our team!!! We are seeking enthusiastic and experienced Executive Chef to join our dynamic team at our newest location of Alta Strada, just off Embassy Row. Ourbrand... 

Alchemy Software Solutions LLC

Senior it policy analyst Job at Alchemy Software Solutions LLC

 ...Oversee and manage all policies including revisions Develop and manage the policy exception process including metrics and reporting Coordinate with key stakeholders on policies and standards across the MBTa Research and evaluate policies to ensure... 

Morgan Stanley

Director, Cybersecurity Risk Assessments Job at Morgan Stanley

 ...providing a wide range of investment banking, securities, investment management and wealth management services. The Firm's employees serve...  ...to draw strategic insight from those analyses. - Strong project management and organization skills; ability to multitask and prioritize... 

E****

Web Visual Designer Needed in Shanghai Job at E****

Web Visual Designer Needed in ShanghaiJD for DesignerWe are a fast-growing E-commerce company - subsidiary of Essilor International and our...  ...Responsibility:1. Define website layout, create unique displays and digital design solutions.2. Define design experience guidance which...