QUALITY ASSURANCE SPECIALIST
Company: Sever Pharma Solutions
Location: Putnam
Posted on: January 27, 2023
Job Description:
SUMMARY Reporting to the QA Supervisor, the Quality Assurance
Specialist position maintains a quality presence which supports all
activities of cGMP regarding pharmaceutical manufacturing, testing
and release to ensure compliance with all relevant pharmaceutical
regulatory requirements: FDA, GMP. Provides QA oversight to
Operations and Analytical Laboratory under direction of the
Supervisor, Quality Assurance. Provides review, impact/risk
assessment analysis, detailed improvement plans for all aspects of
the Quality Systems including but not limited to change controls,
investigations, deviations, complaint handling, and CAPA. Adheres
to Foster Delivery Science's compliance initiatives, including
following all quality and company policy requirements. The Quality
Assurance Specialist independently conducts quality assurance
audits of production/test records (manufacturing, analytical /
quality control records) and facility records assuring company
standards are maintained and product integrity is preserved.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Implements and maintains quality systems, policies and
procedures that ensure compliance to cGMP, FDA (i.e. 21CFR11, 820,
210, 211) and other regulatory standards.
- Performs complex manufacturing batch production record reviews
and approval in support of product release in accordance with
specifications and procedures.
- Performs complex test record data reviews and approval in
support of stability testing and laboratory testing in accordance
with specifications and procedures.
- Provide support to GMP investigations (including
Out-of-Specification),validation documentation review and approval,
identify gaps within existing Quality Systems and propose solutions
for functional management.
- Participates/leads internal/external audits, prepare and issue
audit reports. Recommend remediation actions and follow up on
implementation of the plan.
- Supports resolution of technical and compliance issues/gap
analysis.
- Aides implementation of Quality Systems/System
Improvements.
- Supports and assists with Quality systems-related training,
including compliance with cGMP and SOPs.
- Interface with key quality, manufacturing personnel, and
customers to coordinate documentation impacting quality areas.
- Review/approval of all cGMP documents generated across site to
include (but not limited to): SOPs, technical reports, validation
documents, QA assessment, APQRs, audit documents, change control,
deviation & document revisions, etc---
- Participates and/or leads meetings, associated with primary
batch record review and batch release, non-conformances
investigation and CAPA.
- Work in coordination with regulatory affairs group in support
of regulatory submissions.
- Participates in FDA inspections and customer audits, as
required.
- Provides QA review/approval of all cGMP documents associated
with manufacture of product.
- Communicates with contractors, laboratory personnel and
internal manufacturing/technical groups regarding compliance and
quality issues (i.e., batch documentation, OOS, Stability,
timelines and data related issues).
- Authors or revises SOPs as necessary.
- Actively engaged in the training of staff with lesser
experience or knowledge of quality assurance processes. Educate and
instruct QA and plant personnel in quality best practices for
sampling, labeling, good documentation practices, equipment
sanitation. Confirm these procedures are being adhered to, taking
corrective actions when non-conformances are observed.
- Routinely provide input to quality and operations management
for better operational procedures to improve overall efficiency and
regulatory compliance.
- Assist in development of special department projects and work
in conjunction with quality management.
- Other duties as assigned by Supervisor, Quality Assurance.
SUPERVISORY RESPONSIBILITY
- This position has no direct supervisory responsibilities but
does assist with training of staff of lesser experience in the
group.
- This position may provide leadership to teams or groups formed
for specific objectives. QUALIFICATIONS
- Strong background and demonstrated effectiveness in quality
assurance operation and compliance of commercial medical device /
pharmaceutical in an FDA regulated environment.
- Knowledge of Analytical Laboratory processes, data review and
Laboratory systems.
- Knowledge of plastics manufacturing, analytical testing is
highly desirable.
- Extensive knowledge of FDA and EU cGMP regulations
- Knowledge of pharmaceutical and finished product manufacturing,
analytical testing is desirable.
- Knowledge of electronic manufacturing support systems including
any of the following: EMS and QMS desirable
- Experience with FDA Preapproval Inspection preparation and
management is essential.
- Demonstrated leadership, interpersonal, communication, and
motivation skills.
- Familiarity with the tools, concepts and methodologies of
Quality Management Systems.
- Strong analytical, problem solving, and decision-making skills
(i.e. DMAIC, FMEA, DOE, SPC, Lean)
- Attention to detail is crucial in this position.
- Able to work closely with all other departments within Foster
Delivery Science
- Able to work closely with all customers and suppliers.
- Flexible in handling multiple and changing work assignments
daily.
- Self-reliant in meeting goals and objectives
- Ability to effectively present information and respond to
questions from groups of managers and customers. EDUCATION AND/OR
EXPERIENCE
- Knowledge of science generally attained through studies
resulting in a B.S., or higher, in science, engineering,
biochemistry or related discipline, or its equivalent is preferred.
- Experience in medical device / pharmaceutical regulated
environment with an at least 2 years focused on Quality Assurance /
Systems.
- Working knowledge of FDA/EU regulatory requirements applicable
to pharmaceutical drug products. Ability to apply cGMP regulations
to all aspects of the position.
- Experience executing Change Control, Risk/Impact assessment,
Deviation / EM excursion investigations, OOS/OOT and CAPA. Cleaning
/ process validation experience and demonstrated ability to make
key decisions.
- Strong working knowledge of Microsoft Office products.
Technical writing experience.
- Familiarity with electronic Quality Management Systems.
- Strong knowledge of current Good Manufacturing Practices and
Good Documentation Practices, Part 11 requirements, familiarity
with process and cleaning validation, equipment qualification,
validation of computerized systems and ISO cleanroom standards.
LANGUAGE SKILLS
- Ability to read and interpret documents such as safety rules,
operating and maintenance instructions, and procedure manuals.
- Ability to write detailed procedures and work instructions.
- Ability to speak effectively before groups of customers or
employees of the organization. MATHEMATICAL SKILLS
- Ability to work with mathematical concepts and fundamentals of
applied statistics.
- Ability to apply concepts such as fractions, percentages,
ratios, and proportions to practical situations. REASONING ABILITY
Exercises judgment within generally defined practices and policies
in selecting methods and techniques for obtaining solutions. Makes
sound decisions and applies appropriate notification to management
as appropriate. Ability to deal with problems involving several
concrete variables in standardized situations. CERTIFICATES,
LICENSES, REGISTRATIONS Certificate in Process Improvement and/or
Lean - Highly desirable ISPE, ASQ (American Society for Quality)
and/or ISO certification as an Auditor or Quality Improvement
Associate - desirable PHYSICAL DEMANDS Physical demands of this job
are minimal. The employee must occasionally lift and/or move up to
30 pounds. Working with proper PPE and gowning for cGMP Cleanrooms
and Analytical Laboratories is required. WORK ENVIRONMENT Work is
largely performed in an office environment, laboratory, and
manufacturing facility where one must be aware of the presence of
workplace standards including machinery and testing equipment. Use
of protective gowning for the Clean Room areas and personal
protective equipment (PPE) will be required in some portions of the
facility.
PI201839370
Keywords: Sever Pharma Solutions, New England , QUALITY ASSURANCE SPECIALIST, Other , Putnam, Northeast
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