Work Schedule

Other

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

This position will be responsible for ensuring quality execution of sterile operations with respect to quality inspections for production packaging and inspection for both commercial and product development. Typical work hours are 6am - 6pm, on a 2-2-3 schedule.

Key Responsibilities:

Follow all job-related safety and other training requirements.Perform daily AQL inspections in sterile processes, complete and complete supporting documentation. Provide quality guidance to uncover any errors or deficiencies to assure quality and compliance as required by site procedures and cGMPs.Take appropriate actions during quality assurance activities (e.g. AQL results) to ensure adequate controls in relation to the level of product quality, safety and business risks.Communicate and coordinate with production and other quality assurance as required to resolve issues and compliance concerns per procedural requirements.Participate in troubleshooting quality issues through data review and analysis to resolve next actions or necessary critical issuesEnsures concern of quality issues / events to the appropriate production area and quality managementParticipates in practical process improvement initiatives

Qualifications:

High School diploma / equivalent minimally required.Equivalent combinations of education, training, and meaningful work experience may be considered.1+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required.Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be consideredRequired: Experience in a cGMP environment.Hard-working, demonstrated ownership & responsibility;Ability to self-motivate, provide QA guidance to production colleagues and communicate daily with team members on the quality AQL inspection teamAbility to stand, walk, and repetitive bending for prolonged periods of timeProficiency in non-aseptic gowning, and related knowledge of current good manufacturing processes (cGMP).Position requires 12 hour night shift rotation schedule (2 on-2 off-3 on), some overtime as business requires

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

BENEFITS

We offer competitive remuneration, annual incentive plan bonus, 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.