Pfizer QC Inspector in Vega Baja,
Performs sampling of chemistry and microbiological laboratory samples of raw materials and packaging components. Verify correctness of packaging components against approved component specifications and proof of text. Receive, dispatch- and., keep control of the retained samples room. Performs sampling of the water systems applying aseptically techniques. Performs the statistical evaluations requested by Manufacturing and Packaging areas. Localize, identify and segregate questionable materials and for the sampling of materials to be re-tested.
API, Raw Materials & Bulk Product
Verifies that all received materials complies with receiving requirements as per SOP (COA and/or COC, are from an approved manufacturers and site, lot received previously wasn't rejected.
Inspects API, raw material and Bulk Products to ensure containers comply with requirements in regards to essential information and satisfactory conditions of containers vs receiving documentation
Moves or coordinates movement of materials to be tested to the sampling room, looking in the SAP system it physical location.
Samples materials and products according to statistical and laboratory requirements established following applicable procedures.
Evaluates materials and products sample during sampling for description and foreign matters.
Performs ID Test to raw materials and API's, if required using portable RAMAN or NIR.
Identifies all samples and sampled containers accurately
Documents results and reports complying with good documentation practices.
Enters accurate data in the Inspection electronic logbooks.
Destroys inspected samples following applicable procedures , if applicable.
Performs and documents calibration verification of balances.
Monitors, changes and documents temperatures and humidity of sampling booth and notify the QC Team Leader if any discrepancy is detected.
Localizes, reconciles, identifies and moves questionable materials to the appropriate area. Samples raw materials to be re-tested. Ensure procedures to get the information and report is followed.
Clean sampling booth after each sampling
Inspects packaging component to ensure containers comply with requirements in regards to essential information and satisfactory conditions of containers.
Sampled Packaging components according to statistical and laboratory requirements following the applicable procedures.
Evaluates packaging Components against approved specification and proof of text.
Documents results and sample reports in compliance with good documentation practices.
Gives disposition in the computerized Inventory System to the packaging components and subtracts the samples taken from inventory.
Performs and documents calibration verification of balances.
Retain Samples Room
Picks up finished goods retain samples from packaging areas.
Assures correctness of sample quantity according to SOP requirements.
Segregates samples according to required retention storage time.
Verifies appearance of Bulk and Finished Products samples and reports it in the corresponding document to be sent to QA
Verifies raw materials and packaging components retain samples.
Assigns location to Raw materials, APi's, Bulk, and Finished Products samples in the Retain Room and enters all applicable information in the electronic logbook.
Performs the annual check to reserve samples and reports them.
Dispatches all Non- routine samples requested.
Destroys retains samples according to regulatory and SOP requirements according to schedule.
- Performs water sampling following the schedule and applying aseptically techniques.
Bachelor degree or
Associate Degree or High School graduate with a minimum of two (2) years of experience in the Pharmaceutical Industry in Quality Control Department.
Be able to communicate well and follow instructions. Team collaboration.
Available to provide on call support during weekends and after working hours.
Willing to work irregular hours, weekends and holidays when necessary.
Duties require frequent physical effort working with light material; and working with medium-weight material when Raw Material, API and Bulk lots sampling process. The physical mobility expected is lifting and /or moving. Potential hazard if ergonomic techniques are not used.
Supports the Company's EHS Programs following established policies and procedures, and Corporate EHS Guidelines, and will be trained in all applicable EHS procedures and regulations that apply to specific job functions.
Will ensure that any waste (hazardous, non-hazardous or special waste) generated as part of his/her responsibilities are handled in compliance with applicable environmental regulations and in accordance to established SOP's for handling waste.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Other Job Details:
Last Date to Apply for Job: April 27, 2018
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.