Apex Systems Looking for Manufacturing QA Specialist at Horsham, PA Full Time

Job Description:

Apex Systems has a fantastic contract opportunity for an entry-level QA Specialist to work at a leading Bio-Pharmaceutical company in the Montgomery County area. The ideal candidate will have 0-3 years’ of experience in a Pharmaceutical or Food setting. Ideal candidate will have a BS in the Life Sciences and RECENT GRADUATES WILL BE CONSIDERED!

Quality Associate Specialist

Job Summary

The Quality Associate Specialist, Operations, is part of the Manufacturing Quality Assurance group. Main responsibilities include areas of: Environmental Sampling, Operational Checks, Batch Record Review, and Quality Management Systems. Individual actively engages in “on the floor” Manufacturing Quality Assurance activities.

Reviews all pertinent records, including Batch Production Records; releases product for further internal processes and to final lot disposition review. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, escalates to supervision, and takes action to segregate or place lots on Quality Hold as needed. Initiates Quality Management System records that may include up to events (Deviation/Investigation), Change Control, Hold, Document revisions. Progressively increasing responsibilities within role ladder.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Supports one component of the Generics business, mainly within a single site Business.

Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.

Responsibilities

• Conducts day-to-day execution of sample collection for: critical utilities, environmental monitoring, media fill program, and production monitoring, to ensure that all requirements are met
• Performs sampling with a high degree of efficiency, reliability, and accuracy
• Observes environmental, personnel monitoring, and aseptic manufacturing processes
• Documents execution of environmental monitoring samples into information management systems correctly and accurately
• Oversees maintenance, logbooks, media, and sterilization documents
• Maintains testing equipment in clean order; reports equipment problems to supervisor
• Participates in and observes Aseptic Process Simulations
• Performs day-to-day operations Quality Assurance checks “on the floor” during product manufacturing
• Performs GMP related verifications such as line clearances, cleaning, room inspection, and materials releasing rooms to production
• Learns to monitors and respond to Environmental or Building Automated Alarm responses reports
• Releases product to subsequent steps; participates in quarantine/segregation activities for product and/or sampling sites
• Performs ERP transactions for product release/hold for further processing
• With support, participates and escalates in events identified in production to resolve floor issues.
• Involved in providing Quality direction to operations to resolve floor issues, implement corrections and assures deviations are opened
• Reviews operations records, logbooks, associated batch records and in-process data for completeness and in a timely manner
• Notifies Supervisors about errors that may need further investigation
• With guidance, reconciles record entries with other documentation
• Prioritizes reviews based on production and shipment schedules
• Learns to recognize trends, deviations, and problems, promptly reporting them to supervision.
• Identifies opportunities for improvement and elevates to peers and supervision
• Provides data for metrics to measure business compliance to goals
• Executes computer data entries in Quality Systems or databases
• Follows internal processes related to controlled substances
• Follows procedures to ensure compliance to regulatory requirements
• Assures cGMP, GDP, SOP, compendia and all other requirements are met
• Learns how to perform in-process audits to identify adherence to SOPs and MBR requirements
• Actively participates in training events and maintains compliance with assigned training requirements
• Attends operations shift meetings
• Establishes & maintains effective cross-functional relationships
• Follows all procedures to ensure a safe and compliant work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

Qualifications

• BA/BS degree in a related discipline with 0-1 year relevant experience
• Basic knowledge of science, math, and ability to read and interpret SOPs to function within the scope of procedural requirements
• Knowledge and ability to work with and navigate computer systems; competency in Microsoft Office Suite
• Ability to learn Sterility Assurance aseptic techniques and instruments
• Learns regulatory guidance and compendia (USP/EP/etc.) relevant to parenteral pharmaceutical manufacturing.
• Knowledge of applicable safety and standards guidelines: SOP, cGMP, GDP, GLP, DEA regulations and/or MSDS

Physical Requirements

• Ability to read for extended periods of time
• Extended periods of sitting, standing, walking, reaching, climbing, balancing, kneeling, crouching, crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharmaceutical manufacturing environment with risk of exposure to various chemicals and operating equipment.
• Must occasionally lift and/or move up to 15-25 lbs.
• Ability to wear personal protective equipment, including respirators, gloves, etc.
• Must qualify and maintain access to controlled environmental spaces (Aseptic Garb)
• Specific vision abilities are required by this job include close vision and color vision.
• Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods. The work environment includes the following: Wet or Humid, moving mechanical parts, high, precarious places, and Fumes or airborne particles

Please send resumes to [email protected] for immediate consideration.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.