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QA Specialist II / III

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About Us

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

Job Description

Job Title: Quality Assurance Specialist II / III

Job Type: Full-Time

Job Description: We are seeking a meticulous and experienced Quality Assurance Specialist to join our Quality Assurance team. The ideal candidate will have experience in a sterile fill finish manufacturing environment and a strong understanding of quality assurance principles. This role is vital to ensuring our products meet the highest standards of quality and compliance.

The exact job title will be determined based on the candidate s experience and expertise.

Key Responsibilities:

Develop, implement, and maintain quality assurance programs and procedures.
Conduct audits and inspections of manufacturing processes and facilities to ensure compliance with GMP, SOPs, and regulatory requirements.
Review and approve batch records, deviations, and change controls.
Investigate and resolve quality issues and non-conformances.
Collaborate with cross-functional teams to support continuous improvement initiatives.
Provide training and guidance to staff on quality assurance practices and regulatory requirements.
Prepare and present quality reports and metrics to management.
Stay current with industry trends and regulatory updates.

Qualifications:

Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or a related field.
Minimum of 3-5 years of experience in a quality assurance role within a sterile fill finish manufacturing environment.
Strong knowledge of GMP, FDA regulations, and other relevant quality standards.
Familiarity with EU regulations .
Excellent attention to detail and analytical skills.
Ability to work independently and as part of a team.
Strong communication and documentation skills.
Proficiency in quality management systems and software.

Additional Information

Benefits

80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, parental leave, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Schedule Monday through Friday, dayshift, open to some flexibility

Average salary estimate

$77500 / YEARLY (est.)

min

max

$65000K

$90000K

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What You Should Know About QA Specialist II / III, Pace Analytical

At Pace Life Sciences, we're on a mission to make the world a safer and healthier place, and we're excited to invite you to be part of our journey as a Quality Assurance Specialist II / III. Located in the beautiful Rockingham County, NH, this full-time role is perfect for someone who thrives in a sterile fill finish manufacturing environment and has a solid understanding of quality assurance principles. In this position, you'll be responsible for developing and implementing quality assurance programs to ensure our products meet the highest standards of safety and compliance. Your day-to-day activities will include conducting audits, inspecting manufacturing processes, reviewing batch records, and collaborating with cross-functional teams to support continuous improvement. You'll also have the chance to provide training and guidance to staff, keeping everyone updated on regulatory requirements. With a strong attention to detail and analytical skills, you'll be instrumental in investigating and resolving quality issues, presenting metrics to management, and staying ahead of industry trends. If you have a Bachelor's degree in a scientific discipline and 3-5 years of experience in a similar role, we want to hear from you. Join us at Pace Life Sciences and help us push the boundaries of pharmaceutical innovation while enjoying a supportive work environment that values your contributions!

Frequently Asked Questions (FAQs) for QA Specialist II / III Role at Pace Analytical

What are the responsibilities of a Quality Assurance Specialist II / III at Pace Life Sciences?

As a Quality Assurance Specialist II / III at Pace Life Sciences, you'll develop and maintain quality assurance programs, conduct audits of manufacturing processes, review batch records, investigate quality issues, and provide training to staff. Your expertise will directly contribute to ensuring our products meet regulatory standards and high-quality benchmarks.