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Location: Roselle Site, San Diego, CA
The Drug Product Manufacturing Associate III is responsible for executing GMP production of injectable pharmaceuticals while following all applicable SOPs. This role includes preparing equipment and materials for GMP aseptic production and operating equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines.
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.
Perform various semi-routine manufacturing tasks under the guidelines of established SOPs and cGMP regulations.
Act as a lead in daily operations, ensuring all components are in place, operators are trained, and all documentation is complete prior to finishing a campaign.
Serve as a subject matter expert for a specific piece of equipment.
Schedule manufacturing tasks in accordance with cGMP guidelines under the close supervision of the manufacturing supervisor.
Troubleshoot complex manufacturing processes under cGMP guidelines with oversight from the manufacturing supervisor.
Assists in researching and implementing new methods and technologies to enhance operations.
Prepare components, media, buffers, and other solutions as needed.
Accurately document data and write/review batch records in compliance with cGMP guidelines.
Reliably execute and author well defined SOPs and manufacturing batch records; initiate and write revisions to current GMP/SOP guidelines.
Perform routine maintenance of production equipment and production suites.
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.
Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures
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 of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties the employee is:
occasionally required to sit, and to reach to use computers and other office equipment
constantly stand for extended periods of time, up to four (4) hours/time.
frequently required to lift up to 50 pounds
constantly required to view objects at close and distant ranges with hand and eye coordination
frequently required to communicate with others
constantly performs duties while donning aseptic gowning.
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
High School Diploma required; bachelors in a science or engineering discipline preferred.
Minimum of four (4) years of related work experience in manufacturing, laboratory, mechanical or engineering positions.
Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
Familiarity with cGMP, manufacturing, machine operations, and data entry.
Must be familiar with Microsoft Office applications.
*** The hiring rate for this position is $33.36-$38.92 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.
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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (https://pci.com/)
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.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:
For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair-chance
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.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
