Supervisor, Qc Analytical (Sun-Wed)

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

PCI Pharma Services is seeking a senior QC Analytical supervisor to lead analysts in the analytical laboratory. The role involves prioritizing tasks, conducting OOS investigations, peer-reviewing work, training staff, and performing routine tests on raw materials, in-process samples, and finished products using HPLC, Karl Fischer, and other instruments.

The ideal candidate has 5+ years in analytical chemistry in pharma QC, with a strong CGMP background and leadership experience.

Competenze

• Requires 5+ years of analytical chemistry experience, preferably in QC of pharma manufacturing.
• Experience in a cGMP laboratory is required.
• Prior leadership experience is preferred.

Mansioni

• Prioritize and distribute work to QC analysts in the analytical laboratory.
• Conduct OOS and customer complaint investigations.
• Complete peer review of laboratory work and write/Revise SOPs as needed.
• Train new employees and supervise QC Analytical department.
• Perform routine analytical testing supporting materials, in-process, and finished product testing.

Conoscenze

Analytical Chemistry

cGMP laboratory

Leadership

Written and verbal communication

MS Office

Formazione

Bachelor of Science in a scientific field

Master of Science in a scientific field with 3+ years experience

Strumenti

HPLC

Karl Fischer

Particle Size Analyzer

UV-Vis

Densitometer

Osmometer

Descrizione del lavoro

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Join us and be part of building the bridge between life changing therapies and patients.

Essential Duties and Responsibilities:

• Prioritize and distribute work to the analysts working in the QC Analytical laboratory
• Conduct OOS and customer complaint investigations
• Complete peer review of work executed within the analytical laboratory
• Train new Employees
• Routine Analytical testing of samples supporting incoming raw materials, in-process production and finished product testing
• Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required
• Perform instrument calibrations and preventative maintenance as needed
• Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements
• Write, review and revise SOPs as required
• Other duties as assigned or required

Special Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs. Capacity to work on several tasks simultaneously. Able to organize and prioritize work activities. Must be able to walk and drive between locations. Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves comfortable with working/handling of hazardous materials. TRAVEL – <10%

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities. Interacts with Operations staff, Research and Development staff and clients on a regular basis. Supervises the employees in the QC Analytical departmen

Qualifications:

• 5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
• Experience working in a cGMP laboratory required
• Experience working in a CMO (contact manufacturing/development organization) preferred
• Prior leadership experience is preferred
• Bachelor of Science in a scientific area of study
• Master of Science in a scientific area of study and 3+ years Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
• Ability to prioritize tasks for staff
• Ability to make informed decisions
• Detail oriented
• Strong oral and written communication skills
• Excellent organization skills
• Office Suite experience (Excel, Word, Access, and PowerPoint)
• Excellent interpersonal skills and the ability to communicate well both orally and in in writing
• Ability to multi-task in a dynamic environment with changing priorities
• Resilient, can quickly move forward despite challenges
• A drive to achieve results for self, and the team, and is cable of working with limited supervision
• Positive attitude and strong team, cross team collaboration
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

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