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Work Schedule

12 hr shift/days

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

POSITION SUMMARY

This QA Supervisor is responsible for quality assurance of sterile operations with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Sterile facility for both commercial and product development services products. Oversight by the Quality "On the Floor" team provides quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. **Typical hours would be 6a - 6p on a 2-2-3 rotation.**

Key Responsibilities:

+ Supervise a small team of QA professionals.

+ Lead self and others with respect to: (1) job performance and employee development planning and execution, (2) QA standard work execution and collaboration with other departments to meet quality system objectives, (3) quality system decision making and risk mitigation, and (4) follow procedures while providing sound QA decisions and/or recommendations.

+ Perform daily assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs.

+ Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique. Champions quality culture by aiding personnel in understanding application of policies and controls.

+ Participate in rapid response and provides quality guidance and decision making for RAPID events.

+ Advance deviation events to the appropriate area and quality management

+ Perform quality review and approval of procedures, training documents, and forms, as well as deviation and change control.

+ Participate as QA representative in root cause analysis to support deviation investigations.

+ Perform batch record review.

Qualifications:

+ Associate’s degree in science, technology, engineering, mathematics (STEM) or business is minimally required. A Bachelor's degree in those fields is highly preferred

+ 3+ years of experience in Quality Assurance, Quality control or Operations/Manufacturing

+ 1+ years of experience in a leadership function

+ Previous experience in pharmaceutical industry or cGMP environment required, preferably in aseptic or sterile processes.

Knowledge, Skills, Abilities:

+ Ability to make decisions while taking into account level of risks in regard to compliance and product quality.

+ Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership.

+ Outstanding attention to detail and organizational skills.

+ Hard-Working, demonstrated ownership & responsibility; Ability to lead, support & motivate a team.

+ Ability to work in a fast-paced environment, able to multi-task and results oriented.

+ Effective time management and prioritization skills.

+ Requires discretion and independent judgment.

+ Technical writing skills knowledge.

+ Excellent interpersonal skills, including tact to handle sensitive matters.

+ Highly effective verbal and written communication skills.

+ Professional certifications (ex: CQA) and training (Six Sigma) are a plus.

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.

What We Offer

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!

Compensation

+ Competitive Pay

+ Annual performance-based bonus

+ Annual merit performance-based increase

Excellent Benefits

+ Benefits & Total Rewards | Thermo Fisher Scientific

+ Medical, Dental, & Vision benefits-effective Day 1

+ Paid Time Off & Designated Paid Holidays

+ 401K

+ 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 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.