PCI Pharma Services
Supervisor, QC Analytical Wed to Sat 6:30 AM to 5PM
PCI Pharma Services, Bedford, New Hampshire, us, 03110
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.
Summary of Objective The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Laboratory including completing the majority of the peer review in the department and approving the majority of procedures used in the analytical department. The work includes the testing of in-process samples, finished product samples and raw materials. The QC Analytical Supervisor will communicate with clients regarding Out of Specification and other Quality System Events. The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of his/her responsibilities. Also, must be familiar with cGMPs as they relate to analytical test methodologies and practices.
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; Document 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
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
Work Environment
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 department
TRAVEL –
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 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 capable 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
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
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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.
Summary of Objective The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Laboratory including completing the majority of the peer review in the department and approving the majority of procedures used in the analytical department. The work includes the testing of in-process samples, finished product samples and raw materials. The QC Analytical Supervisor will communicate with clients regarding Out of Specification and other Quality System Events. The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of his/her responsibilities. Also, must be familiar with cGMPs as they relate to analytical test methodologies and practices.
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; Document 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
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
Work Environment
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 department
TRAVEL –
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 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 capable 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
undefined
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.
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