Quality Assurance Operations Specialist
- York, PA
Site Name: USA - Pennsylvania - Marietta
Posted Date: Sep 3 2020
Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this Quality Assurance Operations Specialist role could be an ideal opportunity to explore. The QA Operations Specialist provides a link between operations and the various quality systems.Primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
- Provide advice and counsel on cGMP and related quality assurance issues to the value stream
- Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures.
- Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, line clearance, logbook and documentation review, aseptic processing oversight, 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, et al.
- Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate 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.
- Provide QA review and approval for Validation documents, PQRs and Change Controls.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- 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 have the following characteristics, it would be a plus:
- Minimum of 3 years pharmaceutical experience in Quality Assurance preferably in Biologic Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation.
- 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) and statistical analysis (TQM, SAS) required.
- Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance. Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
"US work authorization is required for this role. Sponsorship is not available for this position"
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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