{"id":3854317,"url":"https://alion.io/job/pci-pharma-services-production-associate","title":"Production Associate","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":10,"ghost_share":0,"stale_share":0.6,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Moorabbin, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-06T05:22:33Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-07T21:40:44Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\n We are PCI.\nOur 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.\nPosition Overview\nThe Production Associate facilitates all steps involved in label text approval and printing, and packaging and labelling activities including;\nobtaining approvals and ensuring that the label text meets TGA and/or applicable country regulatory requirements\nensuring that the printing of labels is in accord with applicable GMP requirements and as per PCI SOPs\ncompleting campaigns in accordance with Batch Records, PCI SOPs, Work Instructions etc. and maintains EHS requirements, and\ncleaning and maintenance verification for facility and equipment.\nPosition Specifics\nensuring all required information for label drafting and label printing received from Project Manager are complied with and executed accordingly\nensuring label text for each project is compliant and ready to be approved by the client/sponsor.\nperforming day-to-day packaging and labelling activities in the production facility as scheduled by the Production Associate Manager.\ncompleting batch records accurately and concurrent with packaging and labelling activities and ensuring all steps listed are completed.\npreparing for line clearance, and removal of any production waste/rubbish once production is completed. Production Associates may be requested to perform line clearance sign off.\nassisting in maintaining of the cGMP facility licence and may be required to assist in facility audits (e.g. PCI internal audits and audits conducted by Clients/Sponsors and Regulatory Authorities).\nUndergoing practical training and be involved in procedural updates and provide input for process designs.\nOther Position Activities\nCompleting company training requirements in accordance with curricula and other training as may be required (e.g. completion of training when SOPs, Work Instructions etc. are updated or new SOPs, Work Instructions etc. are issued that are applicable to production)\nFacilitate all steps leading to label text approval, including preparing the draft label text for review/approval by PCI and Client\nLiaise with all appropriate PCI employees to facilitate the preparation of draft/final label text, including label design decisions\nEnsure that the label text meets PIC/s (Annex-13) and TGA regulatory requirements and in collaboration with the client the applicable country regulatory requirement\nIncorporating variable text information e.g. Batch number, Product Code, Kit Number (as applicable), Retest Date etc as per client requirement\nManage kit lists in accordance with applicable procedures or work instructions\nLiaise with company (or client) approved third party translators as may be required\nEnsure that the printing of labels is conducted in a GMP compliant manner, using the correct base label and ribbon combination, that printing is in accordance with applicable PCI SOP(s) and that the appropriate PCI Forms/Records are completed and retained in the designated locations\nConfirm that the combination of base label and ribbon will deliver a printed label that is fit for purpose for the intended substrate (packaging material) and storage conditions, and for conducting the appropriate rub/smudge/scratch adherence test on labels prior to issuance\nEnsure that the quality of the printed labels obtain Quality approval prior to the labels being issued to production\nProvide printed labels to be ready for production in a timely manner, supported by the applicable records/forms\nEnsure that label printing is undertaken in such a way that there is no risk of mix-up, ensuring line clearance is undertaken prior to commencing each printing episode\nDeface any printed labels that are damaged/not required during the printing process\nReconcile unprinted labels (blank labels) and printed labels that are to be used or rejected at the end of the print run.\nEvaluate options for additional/replacement hardware as applicable\nLiaise with external printers to coordinate printing of labels (as may be applicable)\nEnsuring the required Batch Record has been approved and QA issued prior to use\nEnsuring the required packaging room is ready for use and that appropriate Room logs and registers are completed\nFollowing the company gowning and hygiene requirements\nVerifying 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.\nEnsuring that samples are taken in accordance with the batch record instructions (e.g. retention samples).\nReviewing production batch records and ensuring that these are completed and signed prior to Production Senior Associate review.\nEnsuring that all deviations are reported to the Production Senior Associate or Production Associate Manager.\nMaking sure that production facilities are clean and when appropriate, disinfected.\nCleaning of equipment in accordance with SOPs.\nRemoving waste materials and rubbish from the packaging facilities and placing in the correct bins.\nVerify calibrations of equipment prior to use and records kept/registers completed.\nEnsuring that the premises and equipment are maintained and relevant records kept.\nReviewing labels and randomisation lists against label approval forms and master randomisation lists prior to commencing batch manufacture.\nPreparing, reviewing and maintaining SOPs relevant to the Production facility.\nParticipating in PCI internal audits and third-party audits and assist in responding to audit findings and product complaints/recalls as may be required.\nFollow company EHS requirements\nImplement continuous improvement actions as may be appropriate (e.g. updating SOP(s), Work Instructions and Form(s) applicable to label generation activities and processes)\nCompletion additional tasks as allocated by the Senior Production Associates or Production Associate Manager\nAssisting other departments as required.\nThe role works closely with other Production, Warehouse, Project Management and Quality employees to complete the activities in a cGMP compliant manner\nQualifications, Experience & Behavioral Requirements:\nPrevious industry experience in Pharmaceuticals and/or GMP environment\nBachelor of Science, Pharmacy or related Discipline\nExcellent English written and verbal skills with good attention to detail\nScientific experience\nPrevious industry manufacturing/labelling experience\nHigh level of professionalism, ethics, quality of work, communication and responsiveness at all times \nPositive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values \nAnalytical thinker and solution finder/problem solver \nAttention to detail\nCollaborative, team player \nObjective and robust decision maker \nTrusting and trustworthy \nConscientious and diligent \nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt 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.","description_format":"text","description_chars":8116,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-11-06T05:22:33Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":2,"expected_fill_days":38,"reasons":["conf:8","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-production-associate","json_url":"https://alion.io/job/pci-pharma-services-production-associate.json","meta":{"generated_at":"2026-11-08T06:11:21Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":13444,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1987116},"rest":"https://alion.io/mcp/rest/get_company?id=1987116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpci-pharma-services-production-associate"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fpci-pharma-services-production-associate"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fpci-pharma-services-production-associate"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/pci-pharma-services-production-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-production-associate"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3854317}},{"tool":"search_jobs","arguments":{"company":"pci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3854317},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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