Primary Role:
This is a second shift position. The hours are Wednesday to Saturday from 1400 - 0030. Responsibilities include the issuance and review of batch records/labels, review of test results, and Unpurified bulk product disposition of licensed product. Perform on the floor batch record review. Interpret documentation to ensure operations meet requirements of cGMP, internal SOPs and company policies. The candidate will be required to differentiate between deviations and expected results and resolve compliance issues in a timely manner. The candidate will ensure cGMP documentation is correct, clear and consistent with corporate and regulatory standards. Actively partners with manufacturing operations, providing compliance and technical guidance, to ensure that product quality issues are identified and resolved in a timely manner through applicable quality systems. Perform analysis, identify issues and provide recommendations for compliance improvements. Perform Mfg walkthroughs and provide follow-up and guidance to ensure resolution of observation.
Responsibilities:
Direct responsibilities include:
• Draft, revise and/or approve procedures as required
• Review and approve batch production records, manufacturing logs, and QC test results in support of unpurified bulk disposition
• Daily support of QA on the floor activities in support of manufacturing
• Ensure that documentation and operations meet established requirements of cGMP’s, internal SOP’s and company policies
• Initiate, review and approve deviations
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
Requirements:
Education & Experience Requirements:
Requirements include:
• Bachelor’s degree (BA/BS) in a scientific discipline with a minimum of 3 years industry experience in quality or operations including experience in cGMP, pharmaceutical/medical device systems.
• This position is for a 4 / 10 hour-work night with one weekend night shift along with Holiday coverage.
Key Skills and Competencies:
• Proficiency with Microsoft applications Word, Excel, Project, and Powerpoint; ability to learn additional software applications, as the need arises Trackwise and LIMS experience a plus.
• Ability to work effectively in a fast-paced environment
• Strong written and oral communication skills required • Excellent interpersonal skills required
• Adherence to domestic and international GMP regulations, cGMP’s, company policies, DNA leadership capabilities, performance management and department budget
• Teamwork skills essential
• Strong organizational skills
• Ability to multi-task in a dynamic environment with changing priorities
• Strong prioritization skills
• Self-motivated and driven to independently accomplish department goals and objectives
• Shire expects all employees to live the BRAVE values:
- Build on Integrity: Act with integrity in all you do. Be forth right in a way that builds sustained relationships. Demonstrate respect for the individual, diversity and the environment
- Risk a “Risk”: Believe in your convictions; anything is possible! Take measured risks and create innovative solutions that make a difference.
- Act on the Needs of Patients: With relentless dedication, serve our patients in everything you do. Create a quality customer experience for those you interact with.
- Vie to Be Better Than Yesterday: Demonstrate a true sense of urgency and don't make great ideas wait. Make progress everyday to avoid the complacency that prior success may bring.
- Exemplify Trust & Openness: Trust your colleagues and draw on their input for better outcomes. Collaborate across boundaries and geographies. Build openness through teamwork and focus on tackling business challenges.
Complexity and Problem Solving:
• This individual will be the primary quality assurance representative on 2nd shift and is empowered to make quality assurance decisions.
• It is incumbent upon this individual to bring any concerns to direct supervisor or areas of significant cross- functional disagreement to supervisor.
Internal and External Contacts:
• Besides working closely with the QA Operations Group, this individual will work closely with the following groups:
- Manufacturing
- Facilities and Engineering
Other Requirements:
This is a shift position Wed Sat 1400 - 0030
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