Work Schedule
7 1/2 hr shiftEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Reports to Allentown, PA, Site. CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.
The Operations, Clinical Quality Assurance Inspector will support all Quality functions in relation to packaging activities of clinical product processed through primary and secondary packaging operations. Support of commercial packaging activities is also included. The role involves supporting management and the quality team and close interaction with relevant cross functional groups at the site. The role requires the ability to problem solve and effectively ensure the site follows established quality systems. Additionally, the role requires strong communication skills both verbally and written. Candidate should have experience with cGMP regulations.
Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
Demonstrates and promotes the company vision.
Performs approval of specifications and Incoming Inspections on material (i.e. drug, components) and distribution shipments.
Performs material and process inspections and samplings.
Review and approve Packaging Electronic Production Orders.
Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
Author's, revises and follows all relevant SOP's/Work Instructions and accurately documents activities as needed.
Resolve and assure that issues potentially affecting product quality/compliance are raised to the attention of the Team Leader and/or Management.
Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
Performs all activities in a safe and efficient manner.
Other duties may be assigned to meet business needs.
Associates degree preferred.
High School Diploma, or equivalent required.
At least 2 years of experience in Pharmaceutical, or related regulated industry.
Familiar with Quality Systems (Change Control, Deviations, Complaint Management, Documentation Management, among others).
This job requires the incumbent to work in a refrigerated environment (2° C to 8° C) and freezer environment (-20° C) with provided protective wear.
Must be willing to work various shifts and overtime depending on business needs.
Ability to work independently.
Skills required; to read, understand, and follow the SOP's, Work Instructions and policies of a GMP environment.
Physical Requirements
Extensive standing and walking on packaging floor in order to monitor room activities.
Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
This position requires standing, bending and lifting. Exerting and lifting to 25lbs of materials occasionally, and 10lbs of materials regularly.
The position is exposed to cold temperatures for more than one hour at a time.
The position is exposed to -20F temperatures for at least 15 minutes at a time.
The position will be exposed to atmospheric conditions could require special personal protection equipment.
Position is responsible for inspection of pharmaceutical products, components, and labels. Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
...purpose! Unleash your potential in the world of structural design. APD seeks a Structural Designer ready to leave a mark in our... ...solving prowess and communication skills to truly stand out. Molding the Horizon : Dive deep into projects, working closely with...
...work under pressure and meet deadlines without compromising on quality. 9. Proficiency in project management software tools. 10. PMP or equivalent certification would be considered an asset. 11. Knowledge of safety regulations and quality standards in the construction...
...Job Description Job Description Position title: Clinic RN Department: Clinics Reports To: Clinic Manager Direct Reports: None FLSA Classification: Non-Exempt Position Summary The Clinic RN is responsible for providing direct and indirect patient...
...Services and maintains machines on site Ensures preventive maintenance is performed Ensures machine breakdowns are repaired Ensures... ...good housekeeping Ensures availability of spare parts Manages contractors on site Ensures all employees understand and follow...
...auditing programs to ensure locations conform to legal and company health and safety requirements. Develop annual budgets and manage consultant costs. Emergency and Spill Prevention Planning Identify any needed changes to information contained within individual...