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QA Specialist

Employer
Proclinical Staffing
Location
Pennsylvania, USA, Marietta
Salary
Highly Competitive Salary
Start date
6 Jun 2023
Closing date
20 Jun 2023

View more

Discipline
Quality, QA / QC, QC Analyst
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Proclinical seeking a QA Specialist for a global biopharmaceutical company located in Marietta, PA.

The primary responsibilities for this role are to directly support operations and validation projects that require quality oversight.

Must be eligible to work in the US.

Job Responsibilities:

  • Perform technical review of cGMP documentation, including change controls and validation documents, for completeness and compliance to GMPs as outlined by governmental regulations and internal procedures.
  • Ability to work with a cross functional team at a fast-paced environment
  • Provide advice and counsel on cGMP and related quality assurance issues to the value stream
  • Demonstrate sound decision making relating to quality issues
  • Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, line clearance, documentation review etc.)
  • Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
  • Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, etc.
  • Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate CAPA investigations to address these issues.
  • Write and/or revise controlled documents in support of job responsibilities.
  • Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
  • Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures

Skills and Requirements:

  • BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
  • Minimum of 3 years pharmaceutical experience in Quality Assurance preferably in GMP Biologics Secondary Manufacturing, biotech or pharmaceuticals. Experience in aseptic Filling and Formulation operations preferable.
  • Other Job-related skills background:
  • Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
  • Training and work experience in root cause analysis tools (Isikawa) required.
  • Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance. Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
  • The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write QA documentation as necessitated by regulatory agencies and internal policies.
  • Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
  • Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.

If you are having difficulty in applying or if you have any questions, please contact Miranda Gilmer at +(1) 570-277-7065 or m.gilmer@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-MG2

INDCQA

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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