QA Technician II - Day Shift

Work Schedule

Environmental Conditions

Job Description

QA Technician II QA Audit

Location: Middletown VA

Shift:Standard Days (MF)

Position Summary:

• Responsible for implementing and maintaining the efficiency of the quality system.
• Perform product audits via documentation through batch record review of raw materials components bulks and kits.
• Prioritize work based on ship dates backorders and projects.
• Review maintain and provide as requested documents and records to satisfy international regulatory requirements.
• Assemble documentation requested for product registrations failure investigations and other regulatory requirements.
• Maintain lot history files of batch records for each product released from this operation. This includes filing retrieving and cataloging.
• Acts as a resource to operations teams and problemsolving groups and aids in resolution of problems
• Assist the SAP Coordinators when needed by performing vital MRP/SAP system task activities as part of batch record reviews.
• Alternate work schedule and extended hours will be required to support changes in manufacturing schedule and the need to meet customer expectations on delivery times. Weekend work may be required but minimized as much as possible.
• Review/maintain current customer specifications to ensure the released specifications align with the customers expectations.
• Perform other duties as assigned.

Minimum Requirements/Qualifications:

• Minimum requirement High School Diploma preferred bachelors degree in Science or applicable field.
• Minimum of 2 years of accumulated experience in QA or Quality Control.
• Requires a basic understanding of the practices principles and theory of GMP Services
• Confirmed understanding of the metric system with a focus on weights and volumes. Able to follow/supervise math calculations.
• Communicate effectively both verbally and written with personnel at all levels in a professional manner.
• Function in a team environment and receive direction and mentorship primarily from peers with minimal direction from management.
• Detail oriented and can coordinate multiple activities at once.
• Must be a selfstarter who can take general concepts and direction and produce desirable results.
• Performs other duties as assigned.

Required Hiring Criteria:

• Strong oral and written communication skills. Ability to read write and speak English fluently.
• High attention to detail.
• Ability to work both independently and as a team member
• Basic understanding of Quality practices cGMP regulations and ISO 9001 and ISO 13485 standards.
• Strong leadership skills with the ability to challenge influence and build consensus.

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 1035 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.

What We Offer

Compensation

• Competitive Hourly Pay Rate
• Additional shift differential for 2nd shift and 3rd shift positions
• Annual performancebased bonus
• Annual merit performancebased increase

Excellent Benefits

• Benefits & Total Rewards Thermo Fisher Scientific
• Medical Dental & Vision benefitseffective Day 1
• Paid Time Off & Designated Paid Holidays
• Retirement Savings Plan
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

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 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research tackle sophisticated scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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