Quality Assurance Operations Specialist - Swing Shift

Job Description 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.
This position is a Swing Shift role (11am-8pm).
Flexibility and overtime may be required on holidays and weekends to support project timelines.
Location/Division Specific Information Carlsbad, CA / Microbial Manufacturing Services (MMS) MMS delivers the expertise and resources necessary to help clients deliver innovative therapeutics from process development through commercial supply.
Placed in the forefront of our leading- and cutting-edge plasmid manufacturing business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact? The Quality Assurance Operations Specialist requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment.
The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with MMS directives and procedures, customer requirements, and regulatory standards.
What will you do? Responsible for contributing to key functional, tactical, and operational aspects of MMS operations which includes approval & oversight of MFG and QC activities associated with CAPA, deviations, and other documentation related to MFG and QA operations.
Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections.
Daily check in with operations, quality on the floor for critical operations Records review (e.
g.
Batch Record/Logbook review/PM/CAL review) Quality documentation support for critical MFG operations on the floor Participate in Deviations, Investigations, CAPA, and Change Control Approval of quality documents through the electronic system (TrackWise) Identify process improvement initiatives, procedure generation and compliance opportunities Draft quality procedures as directed by manager Review and approve documents including: Standard Operating Procedures, Batch Records, Specifications, Work Instructions in eDMS Review EM data for Room release and changeovers Support third party audits, external customers, and agency inspections as needed and support internal activities concerning any identified nonconformities.
Perform all activities related to material or product disposition.
Manage projects assigned; multi-task efficiently to ensure timely project completion How will you get here? Education BS in Regulatory & Compliance, Biological Science or related technical field Experience 2+ years of experience in a related Quality position supporting the manufacturing and testing of biologics, medical device, or pharmaceutical products in a cGMP environment Advanced knowledge of U.
S.
and EU regulations, related ICH guideline and industry standards Knowledge, Skills, Abilities Proficiency in Microsoft Suite (Word, Excel, PowerPoint etc.
) Proficient in use of systems such as eDMS, Global TrackWise, SAP (or ERP) etc Ability to make operational quality related decisions independently Skilled technical writer, able to convey complex topics through text and diagrams Have flexibility to work various shifts times if needed to meet department or business goals Self-motivated, with excellent organization skills and detail oriented Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders Strong commitment to customer service and results High ethical standards to support a professional business code of conduct This position has not been approved for relocation assistance.
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! https://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.
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Compensation and Benefits The salary range estimated for this position based in California is –.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
We offer a comprehensive Total Rewards package that our U.
S.
colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.
S.
retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.
thermofisher.
com/global/en/total-rewards