GMP Project Specialist

Primary Talent Partners
US - California - Berkeley
November 15, 2024

Primary Talent Partners has a hybrid 12 month W2 contract with a large biosciences client of ours in the Berkeley, CA area!

The pay range will be from $53.00-57.00/hr without pto, benefits, etc

POSITION SUMMARY

Focus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

POSITION DUTIES & RESPONSIBILITIES

Deviation Management

• Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.

• Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement

• Influences direction of investigations and communicates with all levels of employees

• Write concise, accurate and effective deviation reports for investigations that meet compliance expectations

Change Management

• Coordinate and manage change applications (Local and Global).

• Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures.

• Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters.

• Support process development/improvement projects, site-wide and global projects.

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.

• Minimum Experience BS 6+ years

• MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience

Skill & Competency Requirements: (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)

MUST have experience/expertise in cell and gene therapy manufacturing

• Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.

• Experience with regulatory and cGMP requirements for pharmaceutical manufacturing

• Strong analytical skills to identify root causes and prepare balanced decisions

• Ability to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals.

• Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences.

Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)

• SAP, ValGenesis

• Deviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Client-X)

• Risk Assessments

• Authoring/Reviewing Documents for Regulatory Review

• Lean Six Sigma and Continuous Improvement Methodology

• Project Management Professional (PMP)

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at (url removed)
• PTPJobs
• LI-PTP

Read the full job description and apply online on the recuiter's web-site

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