About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Manufacturing Quality Assurance (MQA) Sr. Supervisor 1st shift will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to MQA personnel. The ideal candidate will possess a working knowledge of aseptic processing requirements, good documentation practices (GDP), good manufacturing practices (GMP) and compliance/regulatory requirements relating to aseptic processing. The incumbent will coordinate timely and accurate batch record reviews and ensure conformance to established procedures and critical process parameters. The MQA Supervisor must be able to identify and effectively communicate any batch related deviations to Production and QA Management in a timely manner. The Sr. MQA Supervisor will perform final audit and final reviews of batch records as required by management.
The essential functions of the position may include, but are not limited to:
• Proficiency of internal manufacturing operations and quality assurance procedures as well as for the area(s) to facilitate compliance and regulatory to regulations requirements.
• Reviews Batch Records for compliance to SOPs and determination of batch acceptability.
• Proficiency in Batch Record reviews for conformance to established procedures and critical process parameters.
• Ability to successfully don a sterile gown and complete gowning qualification requirements to support critical aseptic processing areas (APA).
• Assign records for review per the production schedule. Effectively communicate any delays to management timely.
• Resolves batch related deviations as they are identified.
• Issues weekly batch record review metrics to management and escalate any delays as required.
• Aid in Root Cause Analysis and identification of Preventive Actions to support manufacturing investigations.
• Subject Matter Expert (SME) on the batch record review process, as well as perform final review and final audit of batch records as required prior to sending records to the customers or to 3rd party for release.
• Identifies continuous improvements of Standard Operating Procedures (SOPs) and SOPs / Master Batch Records.
• Participates in internal GMP audits and supports customer and regulatory audits.
Education: BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering or other science related discipline.
Experience: 5 years of pharmaceutical experience or equivalent combination of education and experience. Experience at an aseptic manufacturing site preferred. 1- 2 years of supervisory experience preferred.
• Produces quality work with minimal guidance. Must be able to work in a team environment within own team and across interdepartmental teams.
• Analytical - Able to understand technical concepts and complex manufacturing processes
• Technical Skills - Excellent knowledge of manufacturing operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status.
• Oral Communication - Listens carefully to gather information and able to provide clarification.. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel.
• Team Work - Contributes to building a positive team spirit.
• Written Communication - Writing style adequately describes technical information and the ability to effectively communicate throughout the organization \
• Diversity - Shows respect and sensitivity for personal and cultural differences.
• Interpersonal - Interfaces with management and non-management employees in manufacturing, packaging, Inspection, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories
• Ethics - Works with integrity and ethically. Maintains confidentiality.
• Organizational Support - Supports organization's goals and values. Willing to work together to achieve a common goal.
• Adaptability - Able to deal with frequent change, delays, and/or unexpected events.
• Dependability - Completes tasks on time or notifies appropriate person of impending delays with an alternate course of action.
• Innovation - Meets challenges with resourcefulness.
• Judgment - Exhibits sound and accurate judgment.
• Professionalism - Treats others with respect and consideration regardless of their status or position.
• Quality - Produces analytical work of high quality. Looks for, and suggests ways to improve and promote quality.
• Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements.
Position requires the ability to sit and or stand for extended periods and to work in a variety of settings including office areas, aseptic manufacturing areas, warehouse, etc.
Use of eye protection, gloves and other PPE is required.
Maintaining aseptic area certification may be required.
Practices and promotes safe working environment at all times.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
Must have the ability to simultaneously multi-task across multiple capabilities, functions and manages competing priorities, including performing site and functional responsibilities, frequent e-mail and phone communications and attending multiple meetings and conference calls. Note: these activities may not be time bound to core hours or presence at the site.
Must have the ability to work effectively under strict production schedule, time and performance deadlines.
Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. •1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. •1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
A little about us:
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