Supervisor, Microbiology QC
1 week ago
This is a direct-hire (permanent) position at our client, and will be fully on-site in Philadelphia, PA.
There are two available Night Shifts:
Sunday to Wednesday:
- Week 1: Sunday to Wednesday from 6:00pm - 5:30am
- Week 2: Sunday to Tuesday from 6:00pm - 6:30am
or
Wednesday to Saturday
- Week 1: Wednesday to Saturday from 6:00pm - 5:30am
- Week 2: Thursday to Saturday from 6:00pm - 6:30am
Overview
The Supervisor, Microbiology Testing & Environmental Monitoring supports the environmental monitoring and microbiology testing programs at the company's Cell Therapy Center. This is a working Supervisor role and responsible for overseeing the routine operations and perform testing such as sterility testing, endotoxin testing, media growth promotion, environmental monitoring, plate reading, data review, microbiology investigations, and other microbiology methods as needed to support product release. This position also assists in site and method qualification, validation and commissioning activities. This position works closely with contract labs and vendors to manage outsourced testing.
Essential Functions and Responsibilities
- Oversee day to day operations in the QC Microbiology laboratory in support of environmental monitoring and batch related microbiology testing on the weekend shift.
- Perform daily cGMP quality control laboratory microbiological testing activities and environmental monitoring of the cleanroom areas at the facility as required.
- Schedule and perform routine gas sampling at the facility as required.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Oversee growth promotion testing of microbiological media using both ATCC and in-house isolates.
- Oversee environmental monitoring of the manufacturing areas, including batch related EM, is performed accurately and according to the manufacturing schedule.
- Ensure all in-process and lot release microbiology testing is performed and reviewed accurately and timely.
- Ensure timely review of routine environmental monitoring data, microbiology testing data, and excursions and OOS reports are completed accurately and timely.
- Work closely with contract labs to ensure that samples are submitted and tested in a timely manner.
- Ensure gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas is performed, tracked, and trended.
- Draft and execute protocols in support of site contamination control programs, as needed.
- Oversee the maintenance and built of a microbial identification database for all in-house isolates recovered from the various monitoring programs.
- Work closely with Sterility assurance team to ensure trend analysis and trend reports for environmental monitoring data are performed timely.
- Support site qualification/validation/commissioning activities as needed.
- Serve as a qualified trainer, provides guidance to other analysts.
- Initiate and investigate deviations.
- Mentor and support career development of direct reports.
- Support audits and inspections as needed.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Bachelor’s degree in Biology, Microbiology or related scientific field is required
- Minimum five (5) years of experience in in a cGMP Quality Control microbiology role
- Prior experience in managing a team and having direct reports.
- Basic knowledge of Compendial (e.g., USP, EP, JP, ) requirements and standards
- High proficiency in aseptic techniques when executing microbial test methods and environmental monitoring
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, )
- Strong technical writer with experience in writing protocols, deviations, investigations, SOPs
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
- High level of ownership and accountability
Preferred Education, Skills, and Knowledge
- Experience with cell therapy products is a plus.
Physical Demands and Activities Required:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Must meet requirements for and be able to wear a half-face respirator
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps
- Must be able to use near vision to view samples at close range
- Able to crouch, bend, twist, reach, and perform activities with repetitive motion
- Must be able to lift and carry objects weighing 45 pounds
Work Environment:
- This position will work in both an office and a manufacturing lab setting
- When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals
- Potential exposure to noise and equipment hazards and strong odor
-
Microbiology QC Supervisor
5 days ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeJob Title: Supervisor, Microbiology QCThis is a direct-hire (permanent) position at Planet Pharma, and will be fully on-site in Philadelphia, PA.Job Summary:The Supervisor, Microbiology Testing & Environmental Monitoring supports the environmental monitoring and microbiology testing programs at the company's Cell Therapy Center. This is a working Supervisor...
-
QC Analyst: Microbiology
2 weeks ago
Philadelphia, United States Proclinical Staffing Full timeQC Analyst: Microbiology - Contract - Philadelphia, PAProclinical is actively seeking a Quality Control Analyst for the night shift. This is a contract position located in Philadelphia, PA.Primary Responsibilities:This role is primarily focused on supporting quality control testing operations, including in-process and final drug product microbial testing....
-
QC Associate Microbiology
3 weeks ago
philadelphia, United States Randstad Life Sciences US Full timeExciting Pharmaceutical Company has an open Contract QC Associate Microbiology Position! CompetitivePay: Pay up to $35/HR W2 based on experience. No 1099 or C2C available.Title: QC Associate-MicrobiologyContract: 6 months with potential for renewal/conversion permanentLocation: This is an onsite position in Philadelphia, PA-This is a 1st shift position.Job...
-
QC Associate Microbiology
3 weeks ago
Philadelphia, United States Randstad Life Sciences US Full timeExciting Pharmaceutical Company has an open Contract QC Associate Microbiology Position! CompetitivePay: Pay up to $35/HR W2 based on experience. No 1099 or C2C available.Title: QC Associate-MicrobiologyContract: 6 months with potential for renewal/conversion permanentLocation: This is an onsite position in Philadelphia, PA-This is a 1st shift position.Job...
-
QC Associate Microbiology
3 weeks ago
Philadelphia, United States Randstad Life Sciences US Full timeExciting Pharmaceutical Company has an open Contract QC Associate Microbiology Position! CompetitivePay: Pay up to $35/HR W2 based on experience. No 1099 or C2C available.Title: QC Associate-MicrobiologyContract: 6 months with potential for renewal/conversion permanentLocation: This is an onsite position in Philadelphia, PA-This is a 1st shift position.Job...
-
QC Associate Microbiology
3 weeks ago
philadelphia, United States Randstad Life Sciences US Full timeExciting Pharmaceutical Company has an open Contract QC Associate Microbiology Position! CompetitivePay: Pay up to $35/HR W2 based on experience. No 1099 or C2C available.Title: QC Associate-MicrobiologyContract: 6 months with potential for renewal/conversion permanentLocation: This is an onsite position in Philadelphia, PA-This is a 1st shift position.Job...
-
Supervisor, Microbiology QC
3 weeks ago
Philadelphia, United States Planet Pharma Full timeThis is a direct-hire (permanent) position at our client, and will be fully on-site in Philadelphia, PA. There are two available Night Shifts: Sunday to Wednesday:Week 1: Sunday to Wednesday from 6:00pm - 5:30amWeek 2: Sunday to Tuesday from 6:00pm - 6:30amor Wednesday to SaturdayWeek 1: Wednesday to Saturday from 6:00pm - 5:30amWeek 2: Thursday to Saturday...
-
Supervisor, Microbiology QC
3 weeks ago
Philadelphia, United States Planet Pharma Full timeThis is a direct-hire (permanent) position at our client, and will be fully on-site in Philadelphia, PA. There are two available Night Shifts: Sunday to Wednesday:Week 1: Sunday to Wednesday from 6:00pm - 5:30amWeek 2: Sunday to Tuesday from 6:00pm - 6:30amor Wednesday to SaturdayWeek 1: Wednesday to Saturday from 6:00pm - 5:30amWeek 2: Thursday to Saturday...
-
QC Analyst: Microbiology
1 week ago
Philadelphia, United States Proclinical Staffing Full timeQC Analyst: Microbiology - Contract - Philadelphia, PAProclinical is actively seeking a Quality Control Analyst for the night shift. This is a contract position located in Philadelphia, PA.Primary Responsibilities:This role is primarily focused on supporting quality control testing operations, including in-process and final drug product microbial testing....
-
QC Analyst: Microbiology
1 week ago
philadelphia, United States Proclinical Staffing Full timeQC Analyst: Microbiology - Contract - Philadelphia, PAProclinical is actively seeking a Quality Control Analyst for the night shift. This is a contract position located in Philadelphia, PA.Primary Responsibilities:This role is primarily focused on supporting quality control testing operations, including in-process and final drug product microbial testing....
-
QC Analyst: Microbiology
1 week ago
Philadelphia, United States Proclinical Staffing Full timeQC Analyst: Microbiology - Contract - Philadelphia, PAProclinical is actively seeking a Quality Control Analyst for the night shift. This is a contract position located in Philadelphia, PA.Primary Responsibilities:This role is primarily focused on supporting quality control testing operations, including in-process and final drug product microbial testing....
-
Microbiology Supervisor
1 week ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob SummaryWe are seeking a highly skilled Microbiology Supervisor to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for overseeing the environmental monitoring and microbiology testing programs, ensuring the highest quality standards are met.Key ResponsibilitiesOversee daily operations in the QC Microbiology...
-
QC Microbiology Specialist
6 days ago
Philadelphia, Pennsylvania, United States Randstad Life Sciences US Full timeJob Title: QC Associate MicrobiologyJob Summary:We are seeking a highly skilled Quality Control Associate Microbiology to join our team at Randstad Life Sciences US. As a Quality Control Associate Microbiology, you will be responsible for conducting in-process environmental monitoring of cGMP suites, finished product safety tests, and stability testing...
-
QC Associate Microbiology Specialist
2 weeks ago
Philadelphia, Pennsylvania, United States Randstad Life Sciences US Full timeExciting opportunity at Randstad Life Sciences US for a Contract QC Associate Microbiology Position CompetitivePay: Up to $35/HR W2 based on experience. No 1099 or C2C available.Title: QC Associate-MicrobiologyContract: 6 months with potential for renewal/conversion permanentLocation: Onsite position in Philadelphia, PA-1st shift.Job Summary:The Quality...
-
Quality Control Supervisor, Microbiology
2 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full timeJob SummaryWe are seeking a highly skilled Quality Control Supervisor, Microbiology to join our team at Iovance Biotherapeutics, Inc. This is a critical role that requires a strong background in microbiology and quality control, as well as excellent leadership and communication skills.Key ResponsibilitiesOversee the day-to-day operations of the QC...
-
Microbiology Supervisor
2 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full timeJob SummaryWe are seeking a highly skilled Microbiology Supervisor to join our team at Iovance Biotherapeutics, Inc. The successful candidate will be responsible for overseeing the environmental monitoring and microbiology testing programs, ensuring the highest quality standards are met.Key ResponsibilitiesOversee day-to-day operations in the QC Microbiology...
-
Microbiology Supervisor
7 days ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc. Full timeJob SummaryWe are seeking a highly skilled Microbiology Supervisor to join our team at Iovance Biotherapeutics Inc. The successful candidate will be responsible for overseeing the environmental monitoring and microbiology testing programs, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesOversee day-to-day operations...
-
QC Associate Microbiology
6 days ago
Philadelphia, Pennsylvania, United States Randstad Life Sciences US Full timeJob Title: QC Associate MicrobiologyJob Summary:The Quality Control Associate will be responsible for conducting in-process environmental monitoring of cGMP suites, finished product safety tests, and stability testing associated with drug products.Key Responsibilities:• Conduct in-process environmental monitoring of cGMP suites• Perform finished product...
-
Microbiology Testing Supervisor
2 weeks ago
Philadelphia, Pennsylvania, United States Planet Pharma Full timeJob SummaryWe are seeking a highly skilled Microbiology Testing Supervisor to join our team at Planet Pharma. As a key member of our Quality Control department, you will be responsible for overseeing the routine operations and performing testing in our microbiology laboratory.Key ResponsibilitiesOversee day-to-day operations in the QC Microbiology...
-
Supervisor, Quality Control, Microbiology
1 week ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob Title: Supervisor, Microbiology Testing & Environmental MonitoringAbout Iovance Biotherapeutics Inc.We are a leading biotechnology company dedicated to developing innovative cancer therapies. Our mission is to improve the lives of patients with cancer by delivering cutting-edge treatments that address the unique needs of each individual.Job...