Job Description

The Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham within the Vaccine Manufacturing Facility while actively participating in and embracing an empowered team culture. The Shop Floor Quality Assurance Associate is responsible/accountable for Quality Assurance activities that support BCG manufacturing, including periodic shop floor audits, direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including assessing product impact for events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and Reports

Our Company recently constructed a new manufacturing facility to significantly expand its production capacity for TICE® BCG (BCG Live For Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. This facility will triple our current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future. This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it. The facility includes end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

Second (2nd) shift, Monday thru Friday 2:00pm - 10:30pm. Shift may require coverage Weekends and Holidays.

Position Responsibilities:

• Reporting to the Quality Assurance Organization, will support project assignments for the shopfloor quality team.

• Provide QA shop floor support in the execution and review of GMP documentation such as product and cycle development, stability/engineering batches as well as other technical documents to meet schedule milestones.

• Provide QA shop floor support on batch review, alarm response, incursion response and deviation management.

• Provide QA shop floor support on Aseptic techniques, aseptic observations, cleaning techniques, and gowning observations.

• Partner with site functions to solve problems and achieve goals.

• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.

• Consults with peers and next level manager on more complex decisions.

• Is systematic, timely and appropriately rigorous when making important decisions

• Involves relevant stakeholders in a timely, appropriate manner.

• Proactively seeks out advice and information from others when addressing serious business issues that may impact other functions, geographies, etc.

• Draws accurate conclusions from reports, spread- sheets, and analyses to support decision-making.

• Always shares important and relevant information with the team.

• Develops strong networks and relationships across functions and other organizational boundaries.

• Demonstrates deep understanding of customers' or stakeholders' needs, requirements and expectations.

• Consistently delivers on commitments to customers and stakeholders.

• Continuously seeks new ways to improve the delivery of products and services to customers and stakeholders.

BUSINESS EXPERTISE:

• Basic awareness of management tools and systems to evaluate reports.

• Able to work with constituent groups include but not limited to internal customers (operations, technology and labs)

• Applies understanding and is able to anticipate the needs of customers with constituent groups to ensure product quality and timely resolution of issues.

• Utilizes monitoring, performance tools and systems to ensure product quality, drive Right First Time and compliance standards.

• Able to develop and sustain value-adding relationships with key customers using understanding of key relationships and their importance.

FUNCTIONAL EXPERTISE:

The Shop Floor Quality Assurance Associate role will be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing:

• Direct in-line Quality support for all cGMP compliance, batch review, and environmental monitoring matters.

• Review of batch record documentation (electronic batch record comment resolution, autoclave records, review of electronic and paper batch records as applicable)

• Provide Quality oversight to alarm events (non-viable particles, differential pressure, temperature, and humidity) during processing.

• Review incursions into classified areas for process and environmental impact and approve accordingly.

• Conduct periodic shop floor audits to ensure cGMP compliance.

• Review and classification of atypical events including accessing product impact for events.

• Ensure proper control of materials via product investigations.

• Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations.

• Author and review Standard Operating Procedures specific to the Dept.

• Evaluate environmental data and reports for adverse trends.

• Observe and audit media challenges.

Other:

• Standard Operating Procedure development and review

• Direct support of regulatory inspections and audits

• Direct support of validation activities and all other associated quality functions

• Other duties as requested by management.

PROBLEM SOLVING:

• Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

• Responds to standard requests from clients and/or customers.

IMPACT:

• Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition.

• Influence and Decision Making:

• Represents Quality on the shop floor to influence cGMP compliance and ensure product quality.

• Explains information and persuades others in straightforward situations.

• Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines.

• Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.

PROJECT MANAGEMENT:

• Accountable for quality and/or technical contribution to project team or sub-team; may manage/lead a small project team.

• Basic knowledge of the Quality System Model and relationships across its components

• Understands quality systems relevance and importance when developing quality policies, SOPs and guidelines.

RESOURCE MANAGEMENT:

• Aware of costs and assists in controlling costs related to own work.

Education Minimum Requirement:

• Bachelor’s (or other advanced) Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline.

Required Experience and Skills:

• With bachelor’s degree, 1 year of experience in pharmaceutical operations, pharmaceutical industry or highly regulated industry.

• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

• Second (2nd) shift, Monday thru Friday 2:00pm - 10:30pm. Shift may require coverage Weekends and Holidays.

Preferred Experience and Skills:

• Knowledge of Code of Federal Regulations, EudraLex and other regulatory guidance specific to the pharmaceutical industry.

• Experienced in the methods and approaches of conducting document review & quality audits.

PHYSICAL REQUIREMENTS:

• Ability to sit, stand and move within workspace for extended periods.

• Ability to aseptically gown

• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing, and pulling.

• Ability to travel.

WORKING RELATIONSHIPS:

• Reports to Quality Manager Interacts with employees within own department Frequent interaction with employees from other departments. Interacts with representatives from regulatory agencies. Interacts with external suppliers.

NOTICE FOR INTERNAL APPLICANTS

In 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. VETJOBS #EBRG

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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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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, generally Tuesday, Wednesday and either Monday or 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”.

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:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

Yes

Job Posting End Date:

09/12/2024

*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.

Job Posting End Date:09/12/2024

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:R309167