Aseptic Cleaning Group Lead

PCI Pharma Services•San Diego, CA

6d•$30 - $37

About The Position

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 Details: We are looking for an Aseptic Cleaning Group Lead who performs various manufacturing tasks under the guidelines of established SOP’s and cGMP regulations. The Aseptic Cleaning Group Lead will oversee non-exempt Aseptic Cleaning staff. They are responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate. In addition the Group Lead will review GMP documents and participate in process investigations and deviations while ensuring GMP compliance and inspection-readiness. The Group Lead also assists middle and upper management in interviewing and retaining talent. Schedule: Monday – Thursday 5:30PM – 2:00AM eligible for 10% pay differential Sunday – 9:00am – 5:30PM

Requirements

High School Diploma or equivalent required.
Minimum of four (4) years of relevant experience in a manufacturing or laboratory environment
Minimum of one (1) years of leadership/supervisory experience.
Experience with cGMP, manufacturing, machine operations, and data entry.
Detail oriented with strong verbal and written communication skill
Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
Ability to work independently, within prescribed guidelines, or as a team member.
Familiarity with Microsoft Office applications.
Self-motivated.

Nice To Haves

Previous experience managing cleaning crews, preferred.
GMP aseptic cleaning experience is highly preferred.
Bilingual Spanish speaker is a plus.

Responsibilities

Performs various manufacturing tasks under the guidelines of established SOP’s and cGMP regulations.
Writes deviations, OOS’s, Change controls, and any other investigations pertaining to the group.
Works with management to implement process improvements, trainings, new projects and facility repairs.
Schedules cleaning tasks under cGMP guidelines and under minimal supervision from manufacturing management.
Directs cleaning personnel helping to streamline processes and ensure oversight throughout operations.
Acts as subject matter expert for specific pieces of equipment and processes.
Inventory/Stocks cleaning supplies and equipment.
Monitors activities to ensure adherence to SOPs and proper technique.
Performs cleaning activities as needed.
Submits cleaning updates and provides details about cleaning activities as requested.
Responsible for routine maintenance of cleaning equipment and production suites.
May research and procure equipment for multiple manufacturing processes.
Initiates and writes revisions to current GMP/SOP guidelines.
Reliably executes and writes well defined SOP’s and manufacturing batch records.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.
Champions PCI Pharma Service’s culture and empowers employees to take responsibility for their jobs and goals.
Engages employees by creating a climate in which they want to do their best.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintains employee work schedules.
Provides oversight and direction to the employees in accordance with PCI Pharma Service’s policies and procedures.
Manage non-exempt aseptic cleaning staff.
Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding, as appropriate.
Disciplining and recommending termination when necessary.
Identified recruits, and retains top-notch talent.