5 Merck jobs in Harrisonburg

**Job Description**
The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.
**_Primary Activities_**
+ Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing
+ Partner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findings
+ Gather regulatory intelligence and partner with our Company and CMO management to prepare sites for audits and inspections. Assists sites during audits and inspections to ensure successful outcomes
+ Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/Management councils
+ Provide guidance and consultation services for regulatory reporting (e.g., BPDR, DPR)
+ Author and/or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirements
+ Actively participate in industry organizations such as PDA, PQRI, PhRMA, ISPE, etc.
**Education and Required Experience:**
+ Bachelors degree in Life Sciences, Chemistry, Engineering or related relevant discipline and 10+ years of demonstrated experience within Quality compliance within large molecule manufacturing industry
+ Expert knowledge of GMP requirements for multiple regulatory agencies
+ Expert knowledge of large molecule manufacturing processes (for biologics and/or vaccines) and sterility assurance requirements
+ Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS
+ Experience in health authority inspections
**Required Skills:**
+ Drive Results - set clear performance standards, overcome obstacles; accountable for actions and achieve results
+ Make Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
+ Act with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate
+ Foster Collaboration - ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment
+ Make Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
+ Act with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate
**Preferred Skills/Experience:**
+ Experience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessor
+ Experience creating or assessing remediation plans
#EBRG
Current Employees apply HERE ( Contingent Workers apply HERE ( 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 ( if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights ( GINA Supplement?
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 ( 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".
The salary range for this role is
$169,700.00 - $267,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**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:**
50%
**Flexible Work Arrangements:**
Remote
**Shift:**
1st - Day
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Required Skills:**
Biological Sciences, Biologics, Biopharmaceutics, Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement, GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance, Regulatory Inspections, Vaccine Manufacturing
**Preferred Skills:**
Quality Control Reviews, Remediation Plans
**Job Posting End Date:**
07/27/2025
***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:** R355668

Who We Are and What We Do

Farmer Focus's mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them to farm the way they know is best. We are committed to consistently producing 100% organic and humanely raised chicken that is better for people, the planet, and animals. Our culture is rooted in servant leadership, and we live by our Farmer Focus CARES values: Community, Accountability, Respect, Excellence, and Stewardship.

The Head of Quality Assurance is responsible for leading the Quality Assurance teams to ensure that all Farmer Focus products meet the highest standards of food safety, quality, and regulatory compliance. Reporting to the Head of Operations, this role provides oversight of plant-level QA Managers fostering a collaborative approach to achieving excellence in food safety, quality, and operational standards.

This role is critical in aligning company-wide QA strategies with regulatory requirements and customer expectations while driving continuous improvement initiatives and fostering a culture of accountability and excellence.

Key Responsibilities

• Oversee the development, implementation, and maintenance of Quality Assurance programs, ensuring adherence to USDA, and customer requirements.
• Partner with Live Operations and Compliance departments to ensure quality standards and regulatory compliance in all areas.
• Act as the subject matter expert on food safety, regulatory compliance, and quality systems, providing guidance across cross-functional teams.
• Provide leadership and direction to Plant QA Managers and the Compliance team, ensuring consistent application of food safety and quality standards across all facilities.
• Develop and monitor key performance indicators (KPIs) to track the effectiveness of quality and compliance programs, identifying and driving opportunities for improvement.
• Lead the response to customer, regulatory, and third-party audits, ensuring timely and effective resolution of findings and implementation of corrective actions.
• Manage compliance with organic, humane, and other certification standards, ensuring alignment with company values and regulatory requirements.
• Collaborate with Operations, Engineering, R&D, and other departments to enhance product quality and ensure the hygienic design of facilities and equipment.
• Plan and organize training activities to promote a deep understanding of food safety and quality standards across the organization.
• Investigate and resolve quality and compliance issues, including non-conformance incidents, customer complaints, and product recalls.
• Drive the implementation of continuous improvement initiatives related to HACCP, GMPs, and other preventive controls.
• Provide mentorship, coaching, and professional development opportunities for team members, fostering a culture of growth and accountability.

Qualifications:

• Bachelor's degree in Food Science, Poultry Science, Microbiology, or a related field required; advanced degree preferred.
• Minimum of 7+ years of experience in food safety, quality assurance, or compliance, with at least 3 years in a leadership role.
• HACCP certification required; SQF Practitioner or similar certification preferred.
• Knowledge of BRC or certification highly preferred.
• Strong knowledge of USDA, FDA, and other regulatory requirements applicable to poultry production and food manufacturing.
• Demonstrated ability to lead cross-functional teams and drive continuous improvement initiatives.
• Proven experience managing audits, developing corrective actions, and implementing preventive measures.
• Strong analytical skills with the ability to interpret data and translate insights into actionable improvements.
• Exceptional communication and interpersonal skills, with the ability to influence and inspire teams at all levels.
• Proficiency in Microsoft Office Suite and quality management systems (e.g., Workday, SAP, PI, or similar systems/software).

Work Environment:

• Work is performed in a variety of environments, including office settings, production facilities, and farm visits.
• Frequent exposure to varying temperatures, humidity, and chemicals typical of poultry production facilities.
• Must be able to wear personal protective equipment (PPE) and comply with all food safety and biosecurity requirements.
• Travel to multiple plant locations and off-site meetings required up to 20% of the time.

Farmer Focus is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual's age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Farmer Focus is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment.

At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.

JOB DESCRIPTION

Count on Me - We know what to do, we make it easy, we do our part and we care!

Job Title: FT/PT Quality Assurance Associate

Success Factors Job Code: 1300594

Department: Center Store (Grocery)

Reports To: Assistant Store Manager

Where Applicable: Evening Manager

Primary Purpose:

Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.

Duties and Responsibilities:

• Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
• Courteous and helpful to other associates
• Sweep and clean floors on nights with no scheduled vendor services
• Weekly cleaning of Produce, Market and Deli Departments
• Clean and organize the store mop room
• Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
• Follow QA daily check list and sanitation standards set by Food Lion
• Follow current Standard Practices regarding cleanup of Hazardous Waste product
• Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
• Understand and follow Food Safety and Workplace Safety guidelines and procedures
• Observe and correct all unsafe conditions that could cause associate or customer accidents
• Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
• Ensure compliance with local, state and federal regulations
• Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
• Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
• Perform all other duties as assigned

Qualifications:

• High school graduate or equivalent preferred
• Excellent interpersonal, organizational, communication and customer service skills
• Ability and willingness to learn multiple tasks and technical requirements of the job
• Ability to use technical information to solve problems
• Must meet minimum age requirements to perform specific job functions
• Must be able to meet the physical requirements of the position, with or without reasonable accommodations

Physical Requirements:

• Ability to use computers and other communication systems required to perform job functions
• Perform repetitive hand and arm motions
• Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
• Pull or push up to 75 lbs. on occasion
• Stand 100% of the time, frequently walking short distances
• Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
• Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
• Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
• Meet established volume activity standards for the position
• Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
• Have sufficient visual ability to check ID cards, checks, invoices and other written documents

08/24/2021: Change in job code from 131/132 to SF job code 1300594

Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.

If you have a disability and require assistance in the application process, please contact our Recruiting Department at

At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training.

Primary Purpose:

Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.

Duties and Responsibilities:

• Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
• Courteous and helpful to other associates
• Sweep and clean floors on nights with no scheduled vendor services
• Weekly cleaning of Produce, Market and Deli Departments
• Clean and organize the store mop room
• Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
• Follow QA daily check list and sanitation standards set by Food Lion
• Follow current Standard Practices regarding cleanup of Hazardous Waste product
• Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
• Understand and follow Food Safety and Workplace Safety guidelines and procedures
• Observe and correct all unsafe conditions that could cause associate or customer accidents
• Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
• Ensure compliance with local, state and federal regulations
• Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
• Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
• Perform all other duties as assigned

Qualifications:

• High school graduate or equivalent preferred
• Excellent interpersonal, organizational, communication and customer service skills
• Ability and willingness to learn multiple tasks and technical requirements of the job
• Ability to use technical information to solve problems
• Must meet minimum age requirements to perform specific job functions
• Must be able to meet the physical requirements of the position, with or without reasonable accommodations

Physical Requirements:

• Ability to use computers and other communication systems required to perform job functions
• Perform repetitive hand and arm motions
• Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
• Pull or push up to 75 lbs. on occasion
• Stand 100% of the time, frequently walking short distances
• Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
• Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
• Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
• Meet established volume activity standards for the position
• Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
• Have sufficient visual ability to check ID cards, checks, invoices and other written documents

Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law.

If you have a disability and require assistance in the application process, please contact our Recruiting Department at