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. Purpose & Description: The purpose of the Production Associate is to assist in labelling and packaging campaigns in accordance with the Batch Records, Company SOPs and OHS requirements. The Production Associate is also responsible for facility and equipment cleaning and maintenance as applicable. The role requires extensive hands on work and will work closely with other Production personnel, Storage and Distribution, Projects and Quality staff to complete required production activities in a cGMP compliant manner. Primary Responsibilities: Completing company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs are updated or new SOPs issued that are applicable to production) 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 Following 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 Associate Manager - Production; Making sure that production facilities are clean and when appropriate, disinfected; Cleaning of equipment in accordance with SOPs; Removing waste materials and rubbish from the packaging facilities and placing in the correct bins; Ensure that calibrations of equipment are performed prior to use and records kept/registers completed; Ensuring that the premises and equipment are maintained and relevant records kept; Reviewing labels and randomisation lists against label approval forms and master randomisation lists prior to commencing batch manufacture; Preparing, reviewing and maintaining SOPs relevant to the Production facility; Participating in PCI internal audits and third party audits and assist in responding to audit findings and product complaints/recalls as may be required; Assisting other departments as required Qualifications and Experience: Previous industry experience and/or Bachelor of Science, Pharmacy or related discipline Excellent written and verbal skills with good attention to detail Documented cGMP training Behavioural Competencies: High level of professionalism, ethics, quality of work, communication and responsiveness at all times Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values Analytical thinker and solution finder/problem solver Attention to detail Collaborative, team player Trusting and trustworthy Conscientious and diligent Positive, embraces and responsive to change 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. 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.
