Associate Specialist, Quality

Job DescriptionOur Manufacturing teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.The Quality Operations Laboratory Associate Specialist works with a team of analysts in commercial and pipeline activities at the Durham site.The Quality Operations Laboratory Associate Specialist will be responsible for testing in laboratories using principles of our Company Production Systems, Lean Laboratories, and GMP requirements. The analyst will support routine and non-routine testing, continuing process improvements, troubleshooting, writing Standard Operating Procedures (SOPs), and investigational testing support.Responsibilities may include, but are not limited to:

Work cross-functionally with internal sites to understand, train and ensure successful execution of method transfer activities.

Build relationships to work in a highly functioning diverse team environment.

Support in authoring technical documents, SOPs, and investigations for the performance of laboratory methods.

Execution of method transfers and subsequent release testing/training on multiple methods in overlapping workstreams.

Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing.

Responsible for collaboration on establishing processes that ensure required safety guidelines are followed.

Supports the preparation and participates in audits and training programs in the area of responsibility.

Capability to function effectively within an automated/electronic laboratory environment.

Support digital innovation initiatives on an as-needed basis.

Troubleshoot analytical process and equipment issues as needed from procurement to release testing.

Sample management.

Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

Execute routine and non-routine testing tasks.

Education Minimum Requirement:

At least a Bachelor's degree in science, engineering, or related areas of study.

Required Experience and Skills:

Prior experience with troubleshooting assays, technical writing, and/or aseptic techniques.

Demonstrated interpersonal, technical aptitude, and problem-solving skills.

Experience in using pipettes (single channel, Multichannel).

Experience with the pH meter instrument and analytical balances.

Ability to perform basic scientific math, must have strong computer skills and Proficiency with MS Office applications required.

Must be flexible and able to manage multiple assigned tasks.

Must have attention to details and good documentation skills.

Communicates well with co-workers and superiors.

Ability to analyze data and write up results.

Able to lift 25 lbs.

Preferred Experience and Skills:

At least 1 year of prior pharmaceutical laboratory/manufacturing experience.

Knowledge of cGMP and cGDP.

Knowledge of safety guidelines in a laboratory environment.

Root cause analysis methodology.

Experience in analytical assay execution and method transfer.

Experience in Karl Fisher Moisture, Characteristics, Restoration, or Urea testing.

Method Validation.

Equipment Validation.

NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.#EBRG VETJOBSCurrent Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.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:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):NoJob Posting End Date:11/13/2024A 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: R319494