Jobs for People with MS: National MS Society

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.

• Production Associates have primary responsibility for the day to day labelling and packaging activities in the production facility as scheduled by the Production Lead.

• Production Associates will be responsible for completing batch records concurrent with labelling and packaging activities and ensuring all steps are completed.

• Production Associates will undertake facility cleans and day to day equipment calibrations as required by the batch records and company SOPs and record these activities using the applicable document (e.g. within batch records or using the applicable Forms or Registers).

• Production Associates are responsible for removal of any production waste/rubbish once production is completed and for preparing for line clearance. Production Associates may be requested to perform line clearance sign off.

• Production Associates will be provided with practical training and will be involved in procedural updates and provide input for process designs.

• Production Associates also assist in the maintenance of the cGMP facility license and may be required to assist in facility audits (e.g. PCI internal audits and audits conducted by Clients/Sponsors and Regulatory Authorities).

• Ensuring the required Batch Record has been approved and QA issued prior to use.

• Ensuring the required packaging room is ready for use and that appropriate Room logs and registers are completed.

• Follow the company gowning and hygiene requirements.

• Verifying the picked released stock and equipment for labelling of clinical supplies and packaging, and assembling kits of finished products in accordance with the Batch Records.

• Ensuring that samples are taken in accordance with the batch record instructions (e.g. retention samples).

• Reviewing production batch records and ensuring that these are completed and signed prior to Production Senior Associate review.

• Ensuring that all deviations are reported to the Production Senior Associate or Production Lead.

• Cleaning of equipment in accordance with SOPs.

• Reviewing labels and randomization lists against label approval forms and master randomization lists prior to commencing batch manufacture.

• Preparing, reviewing and maintaining SOPs relevant to the Production facility.

• Assisting other departments as required.

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.

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