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Supervisor, Qc Analytical Jobs

Company

PCI Pharma Services

Address , Bedford, 03110, Nh
Employment type FULL_TIME
Salary
Expires 2023-07-21
Posted at 11 months ago
Job Description
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.

JOB SUMMARY
The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Analytical Laboratory, including data review and writing/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. This also encompasses supporting instrument validations, cleaning validations, and method qualifications as necessary. The QC Analytical Supervisor will communicate with clients regarding OOS test results. The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of their responsibilities and must be familiar with cGMPs as they relate to analytical test methodologies and practices.
JOB DUTIES
  • Supports instrument calibrations and preventative maintenance as needed
  • Other duties as assigned or required
  • Routine Analytical testing of samples supporting incoming raw materials, in-process production and finished product testing
  • Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements
  • Supports cleaning validation studies
  • Write, review and revise SOPs as required
  • Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required
PROFESSIONAL SKILLS
  • Office Suite experience (Excel, Word, Access, and PowerPoint)Bachelor of Science in a scientific area of study
  • Excellent organization skills
  • Strong oral and written communication skills
  • Detail oriented
  • Ability to make informed decisions
  • Ability to prioritize tasks for staff
EXPERIENCE
  • Experience working in a CMO (contact manufacturing/development organization) preferred
  • Experience working in a cGMP laboratory required
  • 5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
  • Prior leadership experience is preferred
EDUCATION
  • Bachelor of Science in a scientific area of study
  • Master of Science in a scientific area of study and 3+ years’ experience Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
QUALITIES
  • Ability to multi-task in a dynamic environment with changing priorities
  • Excellent interpersonal skills and the ability to communicate well both orally and in in writing
  • Resilient, can quickly move forward despite challenges
  • Honesty, integrity, respect and courtesy with leadership and peers
  • Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services
  • 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
PHYSICAL REQUREMENTS AND MENTAL DEMANDS
  • Comfortable with working/handling of hazardous materials
  • Must be able to walk and drive between locations
  • Capacity to work on several tasks simultaneously.
  • Able to organize and prioritize work activities.
  • Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
  • Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 25 lbs.
COMMUNICATIONS & CONTACTS
  • Interacts with Operations staff, Research and Development staff and clients on a regular basis.
  • Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
  • Supervises the employees in the QC Analytical department
TRAVEL – <10%
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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.