Supervisor, QC Analytical Sun to Wed 6:30 AM to 5:00 PM

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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: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• 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

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

• TRAVEL - <10%

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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)Bachelor of Science in a scientific area of study

• 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

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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.