QA Specialist II (2nd Shift)
Role reports to:Manager Plant Quality
Location:North America, United States, Pennsylvania, Lititz
Work Location:Fully Onsite
What you will doPerforms product release on 2nd shift after completing record review and assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices and good laboratory practices as established in the code of local government regulations and company procedures. Provides QA support to operations.
Key Responsibilities- Work with highly engaged and effective team.
- Perform quality review of production records including manufacturing, packaging, and laboratory documents.
- Responsible for releases of finished product based on conformance to established standards.
- Apply quality assurance processes, procedures, and activities.
- Conduct walkthroughs and assessments of GMP areas.
- Partner with Operations to address quality/compliance issues and improvements.
- Complete review of batch records for complaint investigations.
- Generate and distribute certificates of compliance to foreign affiliates.
- Review compliance records, specifications, procedures and other documents, as required by procedure. Limited approval responsibilities.
- Generate, identify and suggest improvements as well as improvements to quality and plant operations.
- Participate in and lead process improvement teams as appropriate.
- Maintain ownership and train others on applicable SOP's. Write and assist others is writing new or updated operating procedures.
- Conduct low risk/low complexity investigations and rationales which are technically accurate and regulatory compliance focused for all quality documentation including non-conformances, corrective actions, CAPAs and audit observation responses, quality reports, metrics. QA management will provide support.
- Independent recommendations to Supervisor regarding compliance decisions with moderate potential impact to business.
- With oversight from manager, prioritize highly complex and diverse workload ensuring results are timely, accurate, and meet their intended objective.
- Assist in document preparation/presentation for regulatory agency visits and Corporate/internal audits.
Ensure quality and compliance in all my actions by:
All employees
- Attend GMP training on the schedule designated for my role and as appropriate for my role.
- Adhere to strict compliance with procedures applicable to my role.
- Exercise the highest level of integrity in the tasks that I perform.
- In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
- Embrace a behavior of employee involvement and commitment to doing the job right the first time.
What we are looking forRequired Qualifications
- A minimum of a Bachelors Degree
- A minimum of 2 years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production.
- Basic working knowledge of cGMP requirements and current FDA enforcement issues.
- Ability to communicate thoughts and ideas effectively - verbal and written.
- Demonstrated ability to accomplish work goals
Preferred Qualifications:
- Proficiency in office productivity software, including advanced skills in Word and Excel
- Strong analytical skills to develop actionable quality strategies and ensure regulatory compliance
- Demonstrated ability to work independently and influence cross-functional teams without direct authority
#LI-SR1
What's in it for youAnnual base salary for new hires in this position ranges:
$72,675.00 - $102,600.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
- Competitive Benefit Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Kenvuer Impact Networks
- This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
