Quality Specialist _ Allentown, PA
Company: Kelly Services
Posted on: April 9, 2021
Quality Specialist _ Allentown, PA--Kelly Services is currently
seeking a Quality Specialist for one of our top clients in
Allentown, PA.Hours: 10am- 7pmPay: $30-35/hourDuration: 6
months--SUMMARY:Provide essential finished Commercial and Clinical
product disposition by performing all aspects of quality batch
issuance, review, verification, disposition, and release activities
across various products in the Pharmaceutical (required), Medical
Devices and/or Biologics industry sectors. You will assure that no
product error has occurred or, if errors occurred, assure that they
have been fully investigated to effectively enable the finished
batch release (approve or reject) disposition. This includes a high
level of functional and technical capabilities, acquired through
experience, qualification training and/or experience to ensure that
each batch of finished Commercial and Clinical product is produced,
sampled, inspected, and tested to ensure that it meets appropriate
- Adheres to the fundamentals of cGMP as stipulated in 21 CFR
Part --4, --11, --210, --211, --600, --820, --1300 and EU Directive
2003/94/EC and other relevant regulations and good documentation
practices with a focus on patient safety.
- Collaborates with Clients to fully comprehend their Batch
review and release requirements and the regulatory obligations
which their company must fulfill.
- Uses sound knowledge of the governing regulations,
authorizations, products, and processes, coupled with the
experience of manufacturing and packaging, and its business
requirements to thoroughly verify all aspects of the batch safety,
identity, strength, purity, and quality.
- Carries out a full qualitative and quantitative analysis of all
inputs into the batch creation process to include the impact
examination of components, manufacturing, packaging, labeling,
inspection, and testing results to confirm compliance.
- Considers all factors that may directly or indirectly affect
the quality of the batch in view, such as environmental monitoring,
analytical results, calibration, validation, preventative
maintenance records, and investigations (Deviations and Complaints)
to include the impact of 'split-site' or 'multiple-site' processing
as part of the final batch release criterion.
- Ensures that only batches of products that have met the
prescribed in-process and finished product specifications and
regulatory requirements are dispositioned to be certified and
released to the market or clinical study site.
- Ensures that batches of products that have not met the
prescribed in-process and finished product specifications and
regulatory requirements are dispositioned to be quarantined or
rejected (when applicable) to prohibit use or release.
- Interacts with Operations, Quality (QA), and internal
functional units for resolution of batch release quality issues or
potential quality issues.
- Proactively identifies clinical batch review concerns and uses
considerable judgment in resolutions and anticipating issues.
- Promptly communicates and escalates (when appropriate) issues
contributing to batch release non-compliance, Out-of-Specification
(OOS), or potential failure to Quality Management. Recommends steps
to resolution, when appropriate.
- Prioritizes batch record data reviews and Client releases to
achieve objectives and deliver compliant results within a
short-term and a long-term operational focus with guidance from the
Production Schedule, Client Services, and Quality Management.
- Maintains both internal and external customer service
expectations with clear, concise communication and a sense of
- Communicates delays promptly to affected parties (Quality,
Supply Chain, Customer Service, etc.).
- Ensures the above-mentioned provisions, to include the
cumulative processing impact are analyzed, and are satisfied before
the finished goods batch is certified to be placed on the
- Represents QA and provides support to internal team meetings,
- Initiates and updates SOPs, as required.
- Trains and mentors' junior staff on interdepartmental processes
and in activities critical to the success of departmental batch
review and verification compliance.
- Reflects the level of batch review compliance innovation to
develop new ideas, methods, techniques, and services.
- Employs metrics to track the performance of Batch
Record/Release Operations and Compliance.
- Supports other business needs, as required.--JOB REQUIREMENTS:
- Bachelor's Degree in a Science related field, Master's Degree
- A minimum of Three (3) years of finished goods commercial batch
record release experience strongly preferred.
- Five (5) years of working pharmaceutical or medical device
experience in a GMP environment, preferably in Quality.
- Have strong knowledge of regulatory requirements including FDA,
EU MHRA, ICH, USP, EU regulations for cGMP, and other regulatory
- Knowledge of manufacturing quality (manufacturing, packaging,
facilities, critical systems, automation, validation, etc.) and
impact on product safety, identity, strength, purity, and quality
- Ability to identify and prevent quality and compliance
- Strong problem solver that uses effective approaches for
choosing a course of action or developing effective and sound
- Take action that is consistent with available facts,
constraints, and probable consequences.
- Proven initiative and demonstrated accountability in a
fast-paced environment with a high degree of flexibility.
- Must be detail-oriented to detect errors or deficiencies on
batch records with the ability to use sound judgment in discerning
if documentation accurately and completely reflects packaging
- Ability to communicate openly and effectively written and
verbal in an engaging manner with colleagues of various levels of
experience and management.
- Experience with Quality Systems (change control, deviations,
complaint management, documentation management).
- Proficient with computers, word processing, and spreadsheet
software (Microsoft Office products).--PHYSICAL REQUIREMENTS:
- This position requires standing, bending, reaching, walking and
talking as well as exerting up to 20 pounds.--Important
information: This position is recruited for by a remote Kelly
office, not your local Kelly branch.-- Applicants must be legally
permitted to work in the United States.-- Email
firstname.lastname@example.org for questions about the position but
please apply online to be considered for the position.--Why Kelly?
- As a Kelly Services employee, you will have access to numerous
- Exposure to a variety of career opportunities as a result of
our expansive network of client companies
- Career guides, information and tools to help you successfully
position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our
Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon
hire*----Apply Today!--*Available for purchase and administered by
a designated third-party vendor--Why Kelly--?Kelly Science &
Clinical is your connection to premier scientific and clinical
companies looking to hire talented people just like you. Every day,
we match science professionals with dream jobs that fit their
skills and interests-it's the way we think job searching should be.
Nearly 100 percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Allentown , Quality Specialist _ Allentown, PA, Other , Northampton, Pennsylvania
Didn't find what you're looking for? Search again!