What are the responsibilities and job description for the Quality Assurance Manager position at BAP Pharma, US?
QUALITY ASSURANCE MANAGER – SOMERSET, NJ
Location: Somerset, New Jersey
Salary: Up to $95-100K Bonus Plan Competitive Benefits
Hours: Full Time, Permanent
Contract: Salaried, Permanent
OUR COMPANY
BAP Pharma is the fastest-growing, independently owned pharmaceutical clinical trials supply organization, with specialist divisions in Comparator Sourcing, Secondary Packaging & Labelling and Global Storage & Distribution. Our story is one of incredible growth and success, which has culminated in receiving many prestigious awards, such as recognition in Diversity & Inclusion and Social & Environmental, and the expansion of our core operations internationally.
Our extraordinary growth and success have enabled investment and expansion of our Secondary Packaging and Labelling division into the USA and 2023 will see the relocation of our US operations to a new state-of-the-art 25,000 sq. ft facility in Somerset, New Jersey – heralding the continuation of our company’s mass expansion and growth.
We are now looking for highly qualified, experienced and passionate professionals who are dedicated to providing unparalleled customer service, to continue to drive our business forward and become a part of our success story.
THE ROLE
The Quality Assurance Manager’s role is to ensure that BAP US Inc. is compliant with cGMP, GDP, FDA, EU and ICH regulatory requirements concerning comparator sourcing, secondary packaging & labelling, release, storage and distribution of medicinal products. The Quality Assurance Manager is responsible for safeguarding product users against potential hazards arising from poor distribution practices and be knowledgeable on relevant US legislation.
The QA Manager will support the senior manager in ensuring that a robust quality management system is implemented and maintained, which ensures that:
- Secondary packaging & labelling, testing and release of investigational medicinal products for clinical trials is compliant with relevant guidelines and regulations.
- IMP batch records are reviewed and approved for release.
- Deviations, complaints, change controls and CAPAs are managed, investigated and performed in a timely manner.
- Shipments and shipping documentation are properly inspected.
- Goods are booked in an accurate and timely manner.
- The delivered product maintains its quality and integrity during storage and transportation and always remains within legal supply chain. Products are delivered to the right recipients within a satisfactory time.
- Monitoring of Warehouse and Cold Room proper temperature conditions.
- Write, review and/or approve SOPs and other quality documents as required.
- Assist with regulatory inspections, customer audits and self-inspections.
- Responsible for supplier and customer qualification prior to sourcing or supplying. Perform on-site audit of suppliers as part of the supplier qualification process where necessary.
POSITION REQUIREMENTS
To be successful in this role you must have;
- Bachelor's degree (or equivalent) in a Science or related field strongly preferred.
- 3-5 years’ experience in the pharmaceutical industry, preferably in the field of comparator sourcing and/or clinical packaging and labelling.
- Familiarity with EQMS, OrderWise, or similar systems.
- Experience hosting/performing internal and external audits would be an advantage.
BENEFITS
- Competitive Bonus plan
- Healthcare
- Dental, vision & life insurance
- 401K contributions
- Paid vacation and sick leave
- Free on-site parking
- Referral programme
- Employee Assistance Programme
- Wellness programme
BAP Pharma is committed to enabling a supportive work environment, which is diverse and inclusive and based on mutual respect. We offer comprehensive training and development programmes to employees to enable them to excel in their roles. We provide our team with a platform in which to continually progress and excel and deliver on our promises to our clients.
BAP Pharma – Promise delivered. Our people are results driven, tenacious and customer focused. If you think you have what it takes to be part of a successful team with an exciting future, please apply today!
Job Type: Full-time
Salary: Up to $105,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Relocation assistance
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Somerset, NJ 08873: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
Salary : $105,000