Job Description
Job Description PRIMARY ACTIVITIES -------------------------------------------- -------------------------- P rimary activities include, but are not limited to: Complaint Management: - Supports the Complaint Management Topic ensuring all product quality complaints (PQC) are investigated within the specified timeframes and Corrective and Preventive Actions are identified when required.
- Assess whether reporting to Health Authority is required.
- Performs trending to identify any specific or recurring problems.
- Approves low and medium risks complaint investigations.
Management Review of Medical Devices and Combination Products: - Supports / executes the Management Review of Medical Devices and Combination Products at the Wilson site including the Quarterly Tracking and Trending and the Annual Management Review.
Other responsibilities: - Manages Deviations and Investigational activities.
- Manages Change Controls.
- Supports the annual product review process.
- Proactively monitors trends and recommends corrective actions to cease performance issues.
- Participates in Internal and external GMP audits and inspections.
- Interprets our Company Quality policies, GMP's and other agency regulations for application to Wilson Operations. Also, mentor others in these decisions.
- Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions. Able to present data to others outside of working group to gain consensus on appropriate path forward.
- Provides Quality Assurance review of all GMP-related SOPs.
- Participates on programs/procedures to improve compliance status of Wilson operations, including investigations and GMP audits.
- Participates on the implementation of new programs/regulations/divisional processes at the site.--
- Identifies continuous improvement opportunities (business and compliance excellence) through the use of lean six sigma methodology and identification of improvement opportunities.
- Participates on divisional/site teams focused on improvement.-----
- Demonstrate leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
Education Requirements: - High School Diploma considered with minimum of 2 years of experience in quality assurance or pharmaceutical industry.
- Bachelor's degree preferred.
Required Skills: - Possesses a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.
- Ability to perform routine assignments and develops competence by performing structured work assignments.-
- Ability to use existing procedures to solve routine and standard problems.-
- Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues.
- Promotes the team's effectiveness through actions that demonstrate respect and appreciation for diverse perspectives.-
- Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.
- Works to develop new skills and abilities.
- Readily accepts performance feedback and incorporates this feedback into future performance.- Assists other team members, including helping with developmental activities.
- Learns to use new problem solving tools to solve issues.
- Ability to interpret our Company Quality Policies, Procedures and Guidelines for daily application.- Developing technical writing capabilities and is able to compile straightforward investigations and procedures.-
- Ability to independently respond to basic requests for data and trending of data.
Preferred Skills - Leverages of IT tools to drive efficiencies and solve complex problems.
- Ability to learn new processes and computerized systems with limited support.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. - All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. - For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: 1st - Day
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 03/20/2025
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R339698
Job Tags
Full time, Local area, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,